MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM

Catalog Number 364940

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1068690.Medical device expiration date: unknown.Device manufacture date: 2021-03-09.Medical device lot #: 1068691.Medical device expiration date: unknown.Device manufacture date: 2021-03-09.Medical device lot #: 1153442.Medical device expiration date: unknown.Device manufacture date: 2021-06-02.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® urine transfer straw the needle inside the transfer straw was dislodged and loose from the straw.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: "there was exposure of the needle which came apart from the holder.Additional information received (b)(6) 2021: "no members of the staff have been injured.".

Manufacturer Narrative

Investigation: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for holder and straw/needle assembly separation was observed.The photo shows the holder has become separated from the straw and needle assembly.Inspections were completed during the production run with no issues being identified.A programming change was completed on 10/22/2021 that would stop the machine if adhesive bond was not applied to the product.The reported batch # 1068690, 1068691 and 1153442 were manufactured before the programming change was implemented.Based on a review of the device history record for the incident lots, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint has been confirmed for the indicated failure mode of holder and straw/needle assembly separation based on the provided photo.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® urine transfer straw the needle inside the transfer straw was dislodged and loose from the straw.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: "there was exposure of the needle which came apart from the holder.Additional information received 2021-11-12: "no members of the staff have been injured.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 2/18/2022.H.6.Investigation: bd received five (5) samples from each batch # (1068690, 1068691, 1153442) and one (1) photo for investigation.The photo was reviewed and the indicated failure mode for holder and straw/needle assembly separation was observed.The photo shows the holder has become separated from the straw and needle assembly.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for holder and straw/needle assembly separation with the incident lot was not observed.When the straw and holder were manually pulled apart, no separation of the needle/straw assembly from the holder was identified.Inspections were completed during the production run with no issues being identified.A programming change was completed on (b)(6) 2021 that would stop the machine if adhesive bond was not applied to the product.The reported batch # 1068690, 1068691 and 1153442 were manufactured before the programming change was implemented.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality notifications.This complaint has been confirmed for the indicated failure mode of holder and straw/needle assembly separation based on the provided photo; however, there were no issues identified with the returned samples.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® urine transfer straw the needle inside the transfer straw was dislodged and loose from the straw.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: "there was exposure of the needle which came apart from the holder.Additional information received 2021-11-12: "no members of the staff have been injured.".

• Brand Name: BD VACUTAINER® URINE TRANSFER STRAW
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12962103
• MDR Text Key: 285011888
• Report Number: 1917413-2021-01046
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364940
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1