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

Catalog Number 364975

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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 that label error occurred before use with bd vacutainer® urine collection cups.The following information was provided by the initial reporter, "we use and distribute at a high volume your product # 364975 which is a urine container with transfer device.We have just received a complaint that the label (caution) on the product would only be in english." as per their contract we should pictograph or have bilingual labels.".

Event Description

It was reported that label error occurred before use with bd vacutainer® urine collection cups.The following information was provided by the initial reporter, "we use and distribute at a high volume your product # 364975 which is a urine container with transfer device.We have just received a complaint that the label (caution) on the product would only be in english." as per their contract we should pictograph or have bilingual labels.".

Manufacturer Narrative

Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.

• 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: 8944916
• MDR Text Key: 156436165
• Report Number: 1917413-2019-01990
• Device Sequence Number: 1
• Product Code: OIE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other