MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD DEVICE URINE TRANSFER STRAW CE; 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 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Investigation summary: 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.Regular inspections occur to check the adhesive bond by applying a force of 5lbs.To make sure the bond will not be broken.The uv sensor is also tested to make sure the glue is cured.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.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the bd device urin transfer straw ce, the device experienced the needle inside the transfer straw dislodging loose from the straw.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: during use the needle part of the product has come away from the holder.The whole batch appears to not have had the straw glued to the pouring device, meaning that they separate and expose a needle.This is obviously a very dangerous needle stick risk for the user.The straws became separated from this defective lot as soon as they were used.As such, we have quarantined the effected lot and taken them out of use for safety reasons.Thankfully, the member of our lab team who first encountered the faulty device managed to avoid a needle stick injury, therefore no members of staff have been injured.Yes, we have 3 full bags and an entire unopened box of these devices if you would like to inspect them further.We received this delivery on the (b)(6) 2021, so quite a recent delivery.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/15/2021.H.6.Investigation: bd received 1300 samples and 1 photo for investigation.The photo was reviewed and the customer¿s 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 observed, as 15 out of 1300 samples revealed the presence of separation.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 # 1127669 was 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 and returned samples.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the bd device urin transfer straw ce, the device experienced the needle inside the transfer straw dislodging loose from the straw.This event occurred 100 times.The following information was provided by the initial reporter.The customer stated: during use the needle part of the product has come away from the holder.The whole batch appears to not have had the straw glued to the pouring device, meaning that they separate and expose a needle.This is obviously a very dangerous needle stick risk for the user.¿ the straws became separated from this defective lot as soon as they were used.As such, we have quarantined the effected lot and taken them out of use for safety reasons.¿ thankfully, the member of our lab team who first encountered the faulty device managed to avoid a needle stick injury, therefore no members of staff have been injured.¿ yes, we have 3 full bags and an entire unopened box of these devices if you would like to inspect them further.We received this delivery on the 8th of september 2021, so quite a recent delivery.

• Brand Name: BD DEVICE URINE TRANSFER STRAW CE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12751707
• MDR Text Key: 280142377
• Report Number: 1917413-2021-00945
• 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
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364940
• Device Lot Number: 1127669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2021
• 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