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

Catalog Number 300865

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

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 a bd plastipak¿ 50ml concentric luer lock syringe became detached from the drug line while the iv was in progress.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: no samples (or pictures) have been received for investigation.Dhr of lot 1711243 is reviewed, not finding any annotation or deviation regarding the alleged defect.Ten retained samples of lot 1711243 are evaluated.Upon visual inspection of these ten retained samples, no damage or molding defect can be observed in the tip or thread of any of them.Tip and thread verification is done with an iso594 compliant gauge pass/non pass (#(b)(4) respectively) to the first lot manufactured in the month per manufacturing line according to procedure (b)(4).Both verifications are done with these gauges and retained samples according to procedure (b)(4).All samples meet iso594 for both verifications.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 ((b)(4)): 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: not confirmed.Since no incident has been found during manufacturing process records related to this defect and according to results obtained from verification with retained samples, no manufacturing defect has been found that could cause the alleged defect and the root cause cannot be determined.

• 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: 7342132
• MDR Text Key: 102591095
• Report Number: 3003152976-2018-00074
• 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: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 1711243
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other