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

Catalog Number 309628

Device Problems Crack (1135); Connection Problem (2900)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Medical device lot #: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported during use of the bd luer-lok¿ disposable syringe the tip on the luer-lok is cracked/damaged when attaching to the connection.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: dhr review could not be performed due to unknown batch #.Sample evaluation: 1 loose 1ml ll syringe was received and reported to be from unknown batch.The sample was visually evaluated.The syringe had damaged/cracked luer collar with pieces of the collar loose in the bag.The remaining collar had visible cracks in it.The device that was being attached to the syringe was not provided.It is unknown from the sample, what was the reason for the collar failure.Due to the sample having been manipulated prior to arrival and the lack of additional supporting information, product defect could not be confirmed to be attributed to the manufacturing process.Photo evaluation: two photos were received by bd canaan and evaluated.A single 1ml ll assembled syringe is depicted in the photos.The luer collar is cracked and shattered in several places with at least one piece on the table next to the syringe.According to the description the failure occurred during attempted connection to another device.It is unknown what device the product was being attached to and how the connection was being handled.There is insufficient information to determine the root cause of the failure at this time.Based on the information available, the failure could not be attributed to the manufacturing process of the syringe.Investigation conclusion: ¿ unconfirmed: bd canaan was not able to duplicate or confirm the customer's indicated failure.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7148550
• MDR Text Key: 96117479
• Report Number: 1213809-2017-00389
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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