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

Catalog Number 300865

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (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 the medication (curare) splattered over a hcw while using a bd plastipak¿ 50ml concentric luer lock syringe.There was no report of exposure to mucous membranes, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: one used sample has been received for investigation of 50ll lot 1712235.Upon visual inspection of the sample received, it can be observed that the barrel of the syringe is broken at the edge of the tip base.No other damage or molding defect can be observed in the syringe barrel.Dhr of lots 1712235 has been reviewed not finding any annotation or deviation regarding the alleged defect.Molding parameters during manufacturing process of this lot have been reviewed finding all of them within specification limits.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.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 two hours, 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: since no molding defect has been found in the sample received and no quality notification happened during manufacturing process of this lot, the root cause of the alleged defect cannot be determined.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7538758
• MDR Text Key: 109239580
• Report Number: 3003152976-2018-00188
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903833221
• UDI-Public: 00382903833221
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1712235
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other