MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ VACUTAINER® URINE COLLECTION TUBE; TRANSPORT CULTURE MEDIUM

Catalog Number UNKNOWN

Device Problems Short Fill (1575); Volume Accuracy Problem (1675); Overfill (2404)

Patient Problem No Information (3190)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

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.Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as bd life sciences - preanalytical systems 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.Investigation conclusion: as bd life sciences - preanalytical systems 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.Root cause description : as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: 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 during use of unspecified bd¿ vacutainer® urine collection tubes, the tubes were under filled.This was not a single event, however the occurrence rate is unknown.(b)(6) also reported that they frequently receive tubes with greater than 8ml or as little as 4ml but believes this is a client dependent issue.It is (b)(6) observation that a urine collection tube filled with less than 7ml is acceptable but wanted to verify with bd as bd has indicated that a sample should be rejected if the tube does not contain 7-8 milliliters.

Manufacturer Narrative

Awareness date for this mdr was 2019-02-04.

Event Description

It was reported that during use of unspecified bd¿ vacutainer® urine collection tubes, the tubes were under filled.This was not a single event, however the occurrence rate is unknown.Labcorp also reported that they frequently receive tubes with greater than 8ml or as little as 4ml but believes this is a client dependent issue.It is labcorp¿s observation that a urine collection tube filled with less than 7ml is acceptable but wanted to verify with bd as bd has indicated that a sample should be rejected if the tube does not contain 7-8 milliliters.

• Brand Name: UNSPECIFIED BD¿ VACUTAINER® URINE COLLECTION TUBE
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8368232
• MDR Text Key: 139098570
• Report Number: 2243072-2019-00323
• Device Sequence Number: 1
• Product Code: KDT
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other