MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER TUBE WITH BD MICROGARD CLOSURE; BLOOD COLLECTION TUBE

Catalog Number	365987
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for plasma leakage from centrifugation was not observed as all samples met specifications.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: 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.
Event or Problem Description
It was reported that after blood collection, a nicu nurse noticed plasma leakage from a bd microtainer tube with bd microgard closure, pst amber, lithium heparin w/gel additive, after centrifugation.The tube was handcarried to the lab and put in another plastic tube.The tube was then placed into a statspin for three minutes.After spinning, processing person picked up microtainer from tube with a forcep but noticed that there wasn't enough specimen and blood was leaking from the base of the microtainer tube.No serious injury or medical intervention reported.

• Brand Name: BD MICROTAINER TUBE WITH BD MICROGARD CLOSURE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7085014
• Report Number: 2243072-2017-00342
• Device Sequence Number: 1183110
• Product Code: JKA
• UDI-Device Identifier: 00382903659876
• UDI-Public: 00382903659876
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: Nurse
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 365987
• Device Lot Number: 429018N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2015
• Initial Report FDA Received Date: 12/05/2017
• 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