BD GP SERIES INFUSION SET
Report
- Report Number
- 9616066-2022-00717
- Event Type
- Malfunction
- Date Received
- June 16, 2022
- Date of Event
- May 19, 2022
- Report Date
- July 20, 2022
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS WHICH MAY HAVE BEEN INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: INVALID LOT #S OF 1022356, 1022289, AND 1022288 WERE PROVIDED BY THE INITIAL REPORTER. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: NA. MEDICAL DEVICE LOT #: 1021907. MEDICAL DEVICE EXPIRATION DATE: 31-JULY2024. DEVICE MANUFACTURE DATE: 01-AUG-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
CORRECTION: AFTER FURTHER REVIEW, THE DEVICE WAS DETERMINED TO BE A DEVICE MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET. THESE DEVICES ARE SOLD OUTSIDE OF THE US AND ARE NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD IN THE US. THEREFORE, THESE PRODUCTS ARE EXEMPT FROM US FDA REPORTING REQUIREMENTS. PLEASE CONSIDER THIS MDR# 9616066-2022-00717 CANCELLED.
H6. INVESTIGATION SUMMARY: FIVE 60693E SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4), IN WHICH THE CUSTOMER OBSERVED LEAKAGE FROM A CRACK IN THE DRIP CHAMBER. OF THE FIVE SAMPLES, ONE WAS RECEIVED WITHOUT PACKAGING, AND WITH RESIDUAL FLUID IN THE LINE. THE OTHER FOUR SAMPLES WERE ALL RECEIVED IN SEALED PACKAGING FROM FOUR DIFFERENT LOT NUMBERS: 1X 1021907, 1X LOT 1022356, 1X LOT 1022288, AND 1X LOT 1022289. EXAMINATION OF THE SAMPLE RECEIVED WITHOUT PACKAGING CONFIRMED THE CUSTOMER'S EXPERIENCE, AS LEAKAGE WAS OBSERVED FROM A VERTICAL CRACK IN THE DRIP CHAMBER BARREL. EXAMINATION OF THE FOUR SAMPLES RECEIVED IN SEALED PACKAGING FOUND NO SUCH DAMAGE, AND NO LEAKAGE WAS OBSERVED AFTER FUNCTIONAL TESTING. AUDIBLE CRACKLING WAS HEARD WHEN THE CHAMBERS WERE FIRST SQUEEZED, BUT NO PHYSICAL DAMAGE OCCURRED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOTS 1022356, 1022288, AND 1022289 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. HOWEVER, A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1021907 DID IDENTIFY ONE PIECE WHICH WAS FOUND TO BE NON-CONFORMING. THE NON-CONFORMING PRODUCT WAS SCRAPPED PER INTERNAL QUALITY PROCESSES. AT THE TIME OF PRODUCTION OF THIS LOT ¿ SEPTEMBER 2021 ¿ NO FURTHER ACTION WAS NECESSARY BEYOND THE REMOVAL OF THE DEFECTIVE ARTICLE; HOWEVER, SINCE THEN THE QUALITY PROCESS FOR THIS TYPE OF ISSUE HAS CHANGED, AND IF ANY SUCH NON-CONFORMING PIECES ARE IDENTIFIED DURING INTERNAL QUALITY CHECKS, THE LOT IS SUBJECTED TO 100% INSPECTION PRIOR TO RELEASE, TO ENSURE NO FURTHER SUCH NON-CONFORMITIES EXIST. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 07-JUN-2022 H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT THE BD GP SERIES INFUSION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING THE INFUSION SET, THE NURSE PRESSED ON THE CHAMBER AND CRACKED IT. VERY FIRST USE OF THE PRODUCT (OUT OF BOX). LEAKAGE OCCURRED AS A RESULT OF THE CRACK. SALINE WAS BEING ADMINISTERED AT THE TIME OF THE EVENT.
IT WAS REPORTED THAT THE BD GP SERIES INFUSION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING THE INFUSION SET, THE NURSE PRESSED ON THE CHAMBER AND CRACKED IT. VERY FIRST USE OF THE PRODUCT (OUT OF BOX). LEAKAGE OCCURRED AS A RESULT OF THE CRACK. SALINE WAS BEING ADMINISTERED AT THE TIME OF THE EVENT.
IT WAS REPORTED THAT THE BD GP SERIES INFUSION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE PRIMING THE INFUSION SET, THE NURSE PRESSED ON THE CHAMBER AND CRACKED IT. VERY FIRST USE OF THE PRODUCT (OUT OF BOX). LEAKAGE OCCURRED AS A RESULT OF THE CRACK. SALINE WAS BEING ADMINISTERED AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1131787 | BD GP SERIES INFUSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |