MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿; CONVENTIONAL SYRINGE

Catalog Number 305959

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that bd plastipak¿ hypodermic syringe luer lok¿ stopper separated during use.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: no samples nor pictures have been received for investigation.Dhr of lot 1805701 has been reviewed finding an annotation related to the alleged defect.During assembly process of this lot, a failure was detected in assembly station that caused the plungers were not correctly fed during assembly to stopper.This failure could have caused the stopper was not correctly assembled to plunger rod and stopper resulted detached during use.Once the failure was detected, defective samples detected were rejected and mechanical team repaired the failure.According to inspection plan procedure jg-500, 200 units are inspected every 2 pallets by quality control team.In addition, final products in this manufacturing line, for this reference and lot size are sampled by operator and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures (jg-301, jg-302, jg-303 and jg-304): visual inspection molding: 2 injections per shift printing: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift assembly: 24 samples per two hours, after any intervention in the equipment and once at the beginning of the shift primary packaging: 1 advance-step (without product) per two hours, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet functional inspection printing: once in the first pallet and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot primary packaging: once in the first pallet and once in last pallet of the lot the manufacturing facility was alerted of the incident.

Event Description

It was reported that bd plastipak¿ hypodermic syringe luer lok¿ stopper separated during use.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8034796
• MDR Text Key: 127892801
• Report Number: 3003152976-2018-00460
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 305959
• Device Lot Number: 1805701
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other