FDA Adverse Event Malfunction Summary report: N

BD SYRINGE¿ WITH NEEDLE

MDR report key: 9598014 · Received January 16, 2020

Report

Report Number: 3002682307-2020-00009
Event Type: Malfunction
Date Received: January 16, 2020
Date of Event: August 22, 2019
Report Date: January 3, 2020
Manufacturer: BECTON DICKINSON, S.A.
Product Code: FMF
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301940 LOT 1811161 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. H3. NOT EVALUATED REASON: SEE H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT A HAIR WAS FOUND IN THE BD SYRINGE¿ WITH NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "BEFORE USING IT, THE NURSE FOUND HAIR IN THE SYRINGE".

Additional Manufacturer Narrative · 1

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 A HAIR WAS FOUND IN THE BD SYRINGE¿ WITH NEEDLE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "BEFORE USING IT, THE NURSE FOUND HAIR IN THE SYRINGE".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
62489	BD SYRINGE¿ WITH NEEDLE	PISTON SYRINGE	FMF	BECTON DICKINSON, S.A.		1811161

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Other