MAUDE Adverse Event Report: BECTON DICKINSON BD SAFETY-LOK¿ BLOOD COLLECTION SET W/OUT LUER ADAPTER 23G X 0.75 IN NEEDLE

Catalog Number	367297
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd received samples from the customer facility for investigation.Ten sets per lot were returned.They were checked visually and there were no apparent defects.The samples were evaluated and the customer's indicated failure mode for faulty seals causing leaks with the incident lot was not observed.A water sampling test was performed and all samples functioned normally without and leakage.Retained samples were tested in the same fashion on (b)(4) sets per lot and no defects were found.A dhr was done and no abnormality, which could be related to the reported event, was found.Conclusion: bd was not able to confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that bd safety-lok¿ blood collection set w/ out luer adapter 23g x 0.75 in needle had 15 of the sets in a row that would not seal and leak all over.No injury or medical intervention reported.

• Brand Name: BD SAFETY-LOK¿ BLOOD COLLECTION SET W/OUT LUER ADAPTER 23G X 0.75 IN NEEDLE
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7077185
• Report Number: 2243072-2017-00300
• Device Sequence Number: 19141319
• Product Code: JKA
• UDI-Device Identifier: 50382903672979
• UDI-Public: 50382903672979
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K980414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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
• Operator of Device: Other
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 367297
• Device Lot Number: 6C2681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2016
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other