MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

Catalog Number 367296

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 05/26/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Bd received 3 photos from the customer facility for investigation.Based on the evaluation of the photos, bd observed that leakage had occurred.A review of the manufacturing records for the incident lot could not be performed as the lot number was not available for review during the investigation.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.The purpose of the luer cap is to prevent the entrance of foreign materials and is not intended to be water-tight, therefore, leakage of air/solution could occur if enough pressure is applied.

Event Description

It was reported that the bd vacutainer® safety-lok¿ blood collection set, w/out luer adapter had blood leakage at the luer.No injury or medical intervention.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7088997
• MDR Text Key: 94754375
• Report Number: 2243072-2017-00321
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672962
• UDI-Public: 50382903672962
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980414
• 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
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367296
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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