MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Thrombus (2101)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: 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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified bd¿ tube experienced clotting/micro clotting after use.The following was provided by the initial reporter: material no.Unknown, batch no.Unknown.It was reported possible sample clotting was witnessed.Called customer to verify complaint issue but no answer; voicemail was left.Email verbiage received, the number of clotted specimens from our nursery improved for a couple of months but now we have had an influx of new nurses and the data is not looking as promising.Would you please contact the nurse with whom you worked before to arrange some more staff training.Thanks.

Manufacturer Narrative

H.6.Investigation summary: as bd had not received any sample, photo, catalog number, and/or lot number from the customer facility for evaluation, an investigation could not be performed as no information was available for review.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 Description

It was reported that an unspecified bd¿ tube experienced clotting/micro clotting after use.The following was provided by the initial reporter: material no.Unknown, batch no.Unknown.-it was reported possible sample clotting was witnessed.Called customer to verify complaint issue but no answer; voicemail was left.Email verbiage received, the number of clotted specimens from our nursery improved for a couple of months but now we have had an influx of new nurses and the data is not looking as promising.Would you please contact the nurse with whom you worked before to arrange some more staff training.Thanks.

• Brand Name: UNSPECIFIED BD¿ TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8761230
• MDR Text Key: 150158500
• Report Number: 2243072-2019-01332
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other