MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309653

Device Problem Crack (1135)

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

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one (1) sample was received from the customer for investigation.The sample was visually examined and was found to have a crack in one (1) side of the barrel.The crack extends about a third 1/3 of the way down the barrel under one (1) of the thumb presses.The thumb press itself is not damaged.Based on the damage to the barrel it appears that the barrel was struck by a hard object at approximately the 40ml gradient line.This impact caused the barrel to crack.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of barrel cracked for lot #8179754 item #309653.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Root cause description: based on the damage to the barrel it appears that the barrel was struck by a hard object at approximately the 40ml gradient line.This impact caused the barrel to crack.

Event Description

It was reported that a crack occurred with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, "the syringe had a very noticeable crack on the side."hello bd, i am writing , about a couple of recent issues we have had with 60ml syringe.Product number is 309653 and affected lot # is 8179754.The first occasion, the technologist was aliquoting a reagent.She tapped on the syringe lightly to remove an air bubble and the syringe had a very noticeable crack on the side.The reagent in the syringe was discarded and the syringe was quarantined.The second occasion, technologist removed the syringe from the packaging and noticed a scratch on the side.Due to the first incident, this syringe was quarantined and a new one used.Both syringes have been saved for inspection.Are there any notices about this syringe or similar incidents happening elsewhere? thank you.".

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8608299
• MDR Text Key: 146983781
• Report Number: 1911916-2019-00467
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2019

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: 07/31/2023
• Device Catalogue Number: 309653
• Device Lot Number: 8179754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other