MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ADAPTER WITH LUER ADAPTER; BLOOD COLLECTION SET

Catalog Number 367300

Device Problem Cut In Material (2454)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Results: a photo of the device was received and the device was returned for evaluation.The indicated failure mode has been verified.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5288548.Conclusion: root cause: the unit may have been inadvertently placed back on the line by an operator after detection by the bision system and pushed into a rework station.

Event Description

It was reported that the bd vacutainer® adapter with luer adapter needle pierced the rubber sheath before use.There was no report injury or medical intervention.

• Brand Name: BD VACUTAINER® ADAPTER WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7066524
• MDR Text Key: 93854184
• Report Number: 1024879-2017-00703
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903673001
• UDI-Public: 382903673001
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K921520
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 367300
• Device Lot Number: 5288548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2016
• 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