FDA Adverse Event Malfunction Summary report: N

BD PLASTIPAK¿ SYRINGE

MDR report key: 7478269 · Received May 1, 2018

Report

Report Number: 3003152976-2018-00179
Event Type: Malfunction
Date Received: May 1, 2018
Date of Event: April 13, 2018
Report Date: June 12, 2018
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: NL
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION CONCLUSION: NO PHYSICAL SAMPLES OR PICTURE SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. TEN RETAINED SAMPLES OF 20LL OF LOT 1801260 ARE EVALUATED. UPON VISUAL INSPECTION OF THESE 10 RETAINED SAMPLES, NO DAMAGE OR MOLDING DEFECT CAN BE OBSERVED IN THEM THAT COULD BE RELATED TO THE ALLEGED DEFECT. DHR OF LOT 1801260 IS REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. INVESTIGATION CONCLUSION: SINCE NO ISSUES WERE IDENTIFIED DURING MANUFACTURING PROCESS AND MANUFACTURING RECORD ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY AND SAMPLES EVALUATED MEET SPECIFICATION LIMITS, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS NOT RELATED TO A MANUFACTURING DEFECT.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. (B)(6). 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 THE PLUNGER ON A BD PLASTIPAK¿ SYRINGE WAS DIFFICULT TO PUSH CAUSING POSSIBLE DOSAGE ERRORS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
318499	BD PLASTIPAK¿ SYRINGE	SYRINGE	FMF	BECTON DICKINSON, S.A.		1801260

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other