MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ LUER-LOK¿ SYRINGE; CONVENTIONAL SYRINGE

Catalog Number 309649

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd plastipak¿ luer-lok¿ syringe leaked chemo medication during use.There was exposure as the customer report states that the ¿assistant had contact with a cytostatic¿ but there was no report of injury or medical interventions.

Manufacturer Narrative

Dhr review for batch 7001992 (p/n 309649): manufacturing date: 02/10/2017 to 02/11/2017.Batch quantity was (b)(4).Assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7001992 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Six photos were received by bd canaan depicting a 5ml syringe reported to be from batch #7001992 (p/n 309649).They were evaluated for leakage past stopper.Some photos where stopper ribs could be seen showed clear space between the ribs with no liquid observed.That indicates no leakage past stopper.No other signs of leakage past stopper could be observed in the photos provided.Unfortunately the photos were of low resolution and could not be studied in more detail.Based on the available photos the defect could not be observed.Root cause and capa not required as no defects were confirmed.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7296239
• MDR Text Key: 100926900
• Report Number: 1213809-2018-00057
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 309649
• Device Lot Number: 7001992
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other