MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VACUTAINER URINE COLLECTION CUP; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 02/18/2021

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.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.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the unspecified bd vacutainer® urine collection cup there was sample leakage.The following information was provided by the initial reporter: translated to english.The customer stated: as i told you, i have had a terrible review of vacuum urine bottles.They spill into the bag.I have received this opinion from almost all branches and over a considerable period of input testing.We believe it is due to the quality of the lid.It would be good if you could make it known, because it seems to me that regarding the value of the input, its quality is quite low.

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the indicated failure mode for leakage with the incident lot was observed.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.The root cause could not be determined.

Event Description

It was reported when using the unspecified bd vacutainer® urine collection cup there was sample leakage.The following information was provided by the initial reporter: translated to english.The customer stated: as i told you, i have had a terrible review of vacuum urine bottles.They spill into the bag.I have received this opinion from almost all branches and over a considerable period of input testing.We believe it is due to the quality of the lid.It would be good if you could make it known, because it seems to me that regarding the value of the input, its quality is quite low.

• Brand Name: UNSPECIFIED BD VACUTAINER URINE COLLECTION CUP
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11457175
• MDR Text Key: 252318186
• Report Number: 2243072-2021-00728
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1