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

Catalog Number 309658

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

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, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6334535, medical device expiration date: 2021-11-30, device manufacture date:2016-11-29.Medical device lot #: 7151895, medical device expiration date: 2022-05-31, device manufacture date: 2017-05-31.

Event Description

It was reported that before use a bd plastipak¿ syringe luer-lok¿ was found with volumetric inaccuracy as ¿the body of the syringe curved or the plungers crooked for small volumes (especially in chemotherapy) leads to an error.¿ there was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: sample evaluation: (updated).25 sealed 3ml packaged syringes were received by bd canaan from 2 different batches.21 sealed packages confirmed to be from batch #7151895 (p/n 309658).4 sealed packages confirmed to be from batch #6334535 (p/n 309658).According to event description it appears the complaint is for stopper angularity.The samples were removed from the syringe packages and visually evaluated.Some of the samples had slight stopper angularity, however it was well within the product specification for this product.No other potential defects were observed in any of the samples.Dhr review for batch 6334535 (p/n 309658): manufacturing date: 12/16/2016 to 12/17/2016 batch quantity was (b)(4).Printing and 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 6334535 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7151895 (p/n 309658): manufacturing dates: 6/6/2017 to 6/7/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7151895 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the sample evaluation: unconfirmed: bd canaan was not able to duplicate or confirm the customer's indicated failure.Investigation conclusion: root cause and capa not required as no defects were confirmed.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7283793
• MDR Text Key: 100661179
• Report Number: 1213809-2018-00054
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096580
• UDI-Public: 30382903096580
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• 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: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309658
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other