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

Catalog Number 300865

Device Problem Device Packaging Compromised (2916)

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

Event Date 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).Initial reporter last name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that before use a bd plastipak¿ concentric luer lock syringe was found with package integrity as ¿packages of around 20 syringes were found to be open." there was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: defect: product non sterile- open seal.It has been received 1 strip of 6 blisters of 50ll lot 1711318 for investigation.Upon visual inspection of the samples received it can be observed the blisters are not sealed in the zone of the tip, the sealing cord is cut by the cutters being the blister open at the tip.It can be observed in the opposite side the peel tab is wider.Dhr of lot 1711318 has been reviewed not finding any annotation or deviation regarding the alleged defect.This defect has been caused due to a de-synchronization in the advance-step of the packing machine which caused the blisters where not cut in the right moment and part of the blister.Final products in this manufacturing line, for this reference and lot size are sampled 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): 1.Visual inspection: molding: 2 injections per shift.Printing: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 32 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 hour, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.2.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.Investigation conclusion: this defect has been caused due to a de-synchronization in the advance-step of the packing machine which caused the blisters where not cut in the right moment and part of the blister.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7331834
• MDR Text Key: 102213835
• Report Number: 3003152976-2018-00079
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1711318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other