MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® SST¿ - AMBER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	365978
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The reported lot # [8236759] was not found for the reported catalog # [365978].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd microtainer® sst¿ - amber wouldn't clot after use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it was reported the customer was experiencing tubes not clotting.Found out about the recall after experiencing issues.This has been occurring for a couple weeks, no specific dates known.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd microtainer® sst¿ - amber wouldn't clot after use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "it was reported the customer was experiencing tubes not clotting.Found out about the recall after experiencing issues.This has been occurring for a couple weeks, no specific dates known.".

• Brand Name: BD MICROTAINER® SST¿ - AMBER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8695757
• Report Number: 2618282-2019-00196
• Device Sequence Number: 2386342
• Product Code: JKA
• UDI-Device Identifier: 50382903659789
• UDI-Public: 50382903659789
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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 Catalogue Number: 365978
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/18/2019
• 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