BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%

Report

Report Number: 9616657-2020-00065
Event Type: Malfunction
Date Received: April 27, 2020
Date of Event: April 7, 2020
Report Date: September 23, 2020
Manufacturer: BECTON, DICKINSON AND CO.
Product Code: NGT
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/13/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SEVENTEEN PROVIDED LOT NUMBERS. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS FOR ANY OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND PHYSICAL SAMPLES WERE RETURNED FOR THE VARIOUS LOT NUMBERS. THROUGH EXAMINATION OF THE PICTURE SAMPLES, THE DEFECTS OF TORN PACKAGING AND FOREIGN MATTER WERE IDENTIFIED; HOWEVER, THE LOTS BELONGING TO THE SAMPLES PICTURED WERE NOT VISIBLE. ALL OF THE PHYSICAL SAMPLES RETURNED EXCEPT FOR THE SAMPLES BELONGING TO LOT NUMBER 7023864 REVEALED SIGNS OF PACKAGE DAMAGE; HOWEVER, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS ISSUE AS A RELATED NON-CONFORMANCE COULD NOT BE IDENTIFIED WITHIN THE MANUFACTURING PROCESS. FOREIGN MATTER WAS OBSERVED ON SEVERAL OF THE RETURNED PHYSICAL SAMPLE PACKAGES. THE FOREIGN MATTER CAPTURED WITHIN THE PICTURE SAMPLES AND SEVERAL PHYSICAL SAMPLES WAS CREATED DURING THE STEAM STERILIZATION PROCESS. THE INTEGRITY OF THE PRODUCT AND THE STERILE BARRIERS HAVE NOT BEEN AFFECTED. THESE SPOTS APPEAR ONLY ON THE OUTSIDE OF THE PACKAGING AND DO NOT PERMEATE IN ANY WAY ONTO THE PRODUCT. FURTHERMORE, MICROBIAL PERMEABILITY TESTING, CYTOTOXICITY TESTING, AND TESTING FOR RESIDUAL SOLVENTS AND VOLATILE SPECIES HAS BEEN COMPLETED ON THE PACKAGES DISPLAYING THE BROWNISH STAIN. THE TESTING CONFIRMED THAT THEY DO NOT PRESENT ANY RISK TO THE USE OF THE PRODUCT AND HAVE NO IMPACT ON THE EFFECTIVENESS, STERILITY, QUALITY OR SAFETY OF BD POSIFLUSH¿ XS 10ML SALINE FLUSH SYRINGE. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT SEVERAL BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% WERE FOUND BEFORE USE WITH TORN PACKAGING. 1 FROM LOT 9101610, 2 FROM LOT 9004801, 7 FROM LOT 9074905, 12 FROM LOT 8185572, 1 FROM LOT 8038554, 2 FROM LOT 7192753, 3 FROM LOT 7305989, 2 FROM LOT 7023864, 5 FROM LOT 0008212, 2 FROM LOT 9178438, 21 FROM LOT 9044641, 4 FROM LOT 8165809, 2 FROM LOT 8136860, 4 FROM LOT 8324558, 2 FROM LOT 9163585, 2 FROM LOT 8099787, AND 1 FROM 8094670. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGE TORN, STERILITY COMPROMISED. 9101610 (1EA), 9004801 (2EA), 8094670 (1EA), 9074905 (7EA), 8185572 (5EA), 8038554 (1EA), 7192753 (2EA), 7305989 (3EA), 7023864 (2EA), 0008212 (5EA), 9178438 (2 EA), 9044641 (21EA), 8165809 (4EA), 8136860 (2EA), 8324558 (4EA), 9163585 (2EA), 8185572 (7EA), 8099787 (2EA)"

Additional Manufacturer Narrative · 1

THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9101610, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31, DEVICE MANUFACTURE DATE: 2019-04-11, MEDICAL DEVICE LOT #: 9004801, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-01-04, MEDICAL DEVICE LOT #: 9074905, MEDICAL DEVICE EXPIRATION DATE: 2022-02-28, DEVICE MANUFACTURE DATE: 2019-03-15, MEDICAL DEVICE LOT #: 8185572, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-07-04, MEDICAL DEVICE LOT #: 8038554, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: 2018-02-07, MEDICAL DEVICE LOT #: 7192753, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30, DEVICE MANUFACTURE DATE: 2017-07-11, MEDICAL DEVICE LOT #: 7305989, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2017-11-01, MEDICAL DEVICE LOT #: 7023864, MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, DEVICE MANUFACTURE DATE: 2017-01-23, MEDICAL DEVICE LOT #: 0008212, MEDICAL DEVICE EXPIRATION DATE: 2022-12-31, DEVICE MANUFACTURE DATE: 2020-01-08, MEDICAL DEVICE LOT #: 9178438, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2019-06-27, MEDICAL DEVICE LOT #: 9044641, MEDICAL DEVICE EXPIRATION DATE: 2022-01-31, DEVICE MANUFACTURE DATE: 2019-02-13, MEDICAL DEVICE LOT #: 8165809, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2018-06-14, MEDICAL DEVICE LOT #: 8136860, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-05-16, MEDICAL DEVICE LOT #: 8324558, MEDICAL DEVICE EXPIRATION DATE: 2021-10-31, DEVICE MANUFACTURE DATE: 2018-11-20, MEDICAL DEVICE LOT #: 9163585, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2019-06-12, MEDICAL DEVICE LOT #: 8094670, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2018-04-04, MEDICAL DEVICE LOT #: 8099787, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2018-04-09. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT SEVERAL BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% WERE FOUND BEFORE USE WITH TORN PACKAGING. 1 FROM LOT 9101610, 2 FROM LOT 9004801, 7 FROM LOT 9074905, 12 FROM LOT 8185572, 1 FROM LOT 8038554, 2 FROM LOT 7192753, 3 FROM LOT 7305989, 2 FROM LOT 7023864, 5 FROM LOT 0008212, 2 FROM LOT 9178438, 21 FROM LOT 9044641, 4 FROM LOT 8165809, 2 FROM LOT 8136860, 4 FROM LOT 8324558, 2 FROM LOT 9163585, 2 FROM LOT 8099787, AND 1 FROM 8094670. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGE TORN, STERILITY COMPROMISED. 9101610 (1EA), 9004801 (2EA), 8094670 (1EA), 9074905 (7EA), 8185572 (5EA), 8038554 (1EA), 7192753 (2EA), 7305989 (3EA), 7023864 (2EA), 0008212 (5EA), 9178438 (2 EA), 9044641 (21EA), 8165809 (4EA), 8136860 (2EA), 8324558 (4EA), 9163585 (2EA), 8185572 (7EA), 8099787 (2EA)".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
467335	BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%	SALINE VASCULAR ACCESS FLUSH	NGT	BECTON, DICKINSON AND CO.		SEE SECTION H.10.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other