MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE COLLECTION CUPS; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364975

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd vacutainer® urine complete cup kits were leaking.The following information was provided by the initial reporter: "it was reported that there are leaky urine cups and the product is flimsy.Special circumstances have prompted (b)(6) medical director to have all primary cups our blue cup be sent to the lab with the tubes.Since implementation, they have noticed that there's a lot of leakage on our cups.4-5 samples per 10.They do a lot of testing and mentioned to us it's a flaw in the design of the cup.Even short samples are leaking and losing all the samples.There are special tests they have to send to one of their offsite lab and they had to use parafim to seal the lid and still leaks after it gets to the other (b)(6) lab.Previous rep mentioned that this is not the first time a pir was submitted.They commented our cups are too flimsy and no matter how good they tighten it, it still leaks.".

Event Description

It was reported that bd vacutainer® urine complete cup kits were leaking.The following information was provided by the initial reporter: "it was reported that there are leaky urine cups and the product is flimsy.Special circumstances have prompted stanford medical director to have all primary cups our blue cup be sent to the lab with the tubes.Since implementation, they have noticed that there's a lot of leakage on our cups.4-5 samples per 10.They do a lot of testing and mentioned to us it's a flaw in the design of the cup.Even short samples are leaking and losing all the samples.There are special tests they have to send to one of their offsite lab and they had to use parafim to seal the lid and still leaks after it gets to the other stanford lab.Previous rep mentioned that this is not the first time a pir was submitted.They commented our cups are too flimsy and no matter how good they tighten it, it still leaks,".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.

Manufacturer Narrative

The following fields were corrected with additional information: d.4.Device material number: 364975; udi number: (b)(4).D.2.Type of device: kdt; common device name: specimen transport and storage contained.D.1.Bd vacutainer® urine collection cups.G.5.510k number: exempt.B.5.Event description: it was reported that bd vacutainer® urine collection cups were leaking.The following information was provided by the initial reporter: "it was reported that there are leaky urine cups and the product is flimsy.Special circumstances have prompted stanford medical director to have all primary cups our blue cup be sent to the lab with the tubes.Since implementation, they have noticed that there's a lot of leakage on our cups.4-5 samples per 10.They do a lot of testing and mentioned to us it's a flaw in the design of the cup.Even short samples are leaking and losing all the samples.There are special tests they have to send to one of their offsite lab and they had to use parafim to seal the lid and still leaks after it gets to the other stanford lab.Previous rep mentioned that this is not the first time a pir was submitted.They commented our cups are too flimsy and no matter how good they tighten it, it still leaks,".

Event Description

It was reported that bd vacutainer® urine collection cups were leaking.The following information was provided by the initial reporter: "it was reported that there are leaky urine cups and the product is flimsy.Special circumstances have prompted stanford medical director to have all primary cups our blue cup be sent to the lab with the tubes.Since implementation, they have noticed that there's a lot of leakage on our cups.4-5 samples per 10.They do a lot of testing and mentioned to us it's a flaw in the design of the cup.Even short samples are leaking and losing all the samples.There are special tests they have to send to one of their offsite lab and they had to use parafim to seal the lid and still leaks after it gets to the other stanford lab.Previous rep mentioned that this is not the first time a pir was submitted.They commented our cups are too flimsy and no matter how good they tighten it, it still leaks,".

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 9940411
• MDR Text Key: 187759536
• Report Number: 1917413-2020-00370
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other