MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN); BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365987
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #:unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that blood was found in centrifuge tube with a bd microtainer® pst¿ tubes with lh (lithium heparin).The following information was provided by the initial reporter: it was reported that blood was found in centrifuge tube bucket.Leading staff to believe it went through plastic while spinning.Plasma and gel separator still intact in tube.Customer reported, - "when taking sample out of centrifuge, noticed that bottom of tube was bloody.The centrifuge well that sample was in was full of blood.Appeared as if red cells were forced out bottom of tube during centrifugation (plasma and gel still in tube).Happened on two separate occasions <1 month apart in two different wells in the centrifuge.
Event or Problem Description
It was reported that blood was found in centrifuge tube with a bd microtainer® pst¿ tubes with lh (lithium heparin).The following information was provided by the initial reporter: it was reported that blood was found in centrifuge tube bucket.Leading staff to believe it went through plastic while spinning.Plasma and gel separator still intact in tube.Customer reported, - "when taking sample out of centrifuge, noticed that bottom of tube was bloody.The centrifuge well that sample was in was full of blood.Appeared as if red cells were forced out bottom of tube during centrifugation (plasma and gel still in tube).Happened on two separate occasions <1 month apart in two different wells in the centrifuge.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that complaint of previously submitted mfr.Report # 2618282-2019-00141 / patient identifier (b)(6).Therefore, this complaint will be canceled.

• Brand Name: BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8508805
• Report Number: 2618282-2019-00159
• Device Sequence Number: 19532500
• Product Code: JKA
• UDI-Device Identifier: 50382903659871
• UDI-Public: 50382903659871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 12/31/2019
• Device Catalogue Number: 365987
• Device Lot Number: 827652N
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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