MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿; BLOOD COLLECTION TUBE

Catalog Number 369714

Device Problems Component Falling (1105); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Multiple lots referenced in the complaint: medical device lot # 5154604, medical device expiration date: 12/31/2016, device manufacture date: 06/03/2015.Medical device lot # 5272777, medical device expiration date: 04/30/2017, device manufacture date: 09/29/2015.Medical device lot # 5120623, medical device expiration date: 11/30/2016, device manufacture date: 04/30/2015.Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for cap pop off with the incident lot was not observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for cap pop off was not observed as all samples met specifications.A review of the manufacturing records was completed for all three incident lots and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.

Event Description

It was reported that during collection the blue top of 13 x 75 mm x 4.5 ml bd vacutainer® glass plasma tube.Lt.Blue bd hemogard¿ came off in the holder causing blood to spill.No blood exposure to mucous membrane.No injury or medical intervention.

• Brand Name: BD VACUTAINER® GLASS PLASMA TUBE. LT. BLUE BD HEMOGARD¿
• Type of Device: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7115167
• MDR Text Key: 95073073
• Report Number: 1917413-2017-00601
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903697149
• UDI-Public: 50382903697149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 369714
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2016
• 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