MAUDE Adverse Event Report: BECTON DICKINSON BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN); BLOOD COLLECTION TUBE

Catalog Number	365987
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 bd microtainer® pst¿ tubes with lh (lithium heparin) had clotting.
Event or Problem Description
It was reported that bd microtainer® pst¿ tubes with lh (lithium heparin) had clotting.
Additional Manufacturer Narrative
The additional information is as follows: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 824092n.Medical device expiration date: 2019-10-31.Device manufacture date: 2018-08-28.Medical device lot #: 822855n.Medical device expiration date: 2019-10-31.Device manufacture date: 2018-08-16.He manufacturing location for this product is juncos.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.
Additional Manufacturer Narrative
Investigation summary: 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/testing and upon completion, no issues were observed relating to the additive as all samples met specifications.A review of the device history record was completed for the incident lots and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd technical support services had reached out to the customer and provided troubleshooting & guidance.It was determined the customer was overfilling the tubes and not mixing them during processing which likely attributed to the clotting issue.Investigation conclusion: based on evaluation of the retain samples, there were no issues found with the additive as all samples met the required specifications.Root cause description: based on the investigation, the most likely root cause was attributed to the customer overfilling and not mixing the tubes during processing.Furthermore, the retain product was found to be in conformance and meet release specifications.
Event or Problem Description
It was reported that bd microtainer® pst¿ tubes with lh (lithium heparin) had clotting.

• Brand Name: BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8187104
• Report Number: 2243072-2018-01876
• Device Sequence Number: 2111869
• Product Code: JKA
• UDI-Device Identifier: 50382903659871
• UDI-Public: 50382903659871
• 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,Followup
• Report Date (Section B): 02/06/2019

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: 365987
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 12/10/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/10/2019; 02/06/2019
• 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