MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH TUBING AND LUER ADAPTER

Catalog Number 367292

Device Problem Sticking (1597)

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

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4)has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd vacutainer® safety-lok¿ blood collection set with tubing and luer adapter "the user stated that after removing a safety-lok wingset from the package, she noticed that the needle was sticking through the rubber sleeve.The product was not used." there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received a sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for the sleeve pierced by the needle with the incident lot was observed.Additionally, retention samples were selected from inventory for visual inspection and upon completion, the customer's indicated failure mode was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer sample, the customer¿s indicated failure mode for side-pierced sleeve with the incident lot was observed.Evaluation of the retain samples was conducted and side pierced sleeves were not observed.Root cause description: based on the investigation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH TUBING AND LUER ADAPTER
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7259227
• MDR Text Key: 100024313
• Report Number: 2243072-2018-00031
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672924
• UDI-Public: 50382903672924
• Combination Product (y/n): N
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 367292
• Device Lot Number: 5J1471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Date Manufacturer Received: 01/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other