MAUDE Adverse Event Report: BECTON DICKINSON BD CUP URIN CE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364941

Device Problems Protective Measures Problem (3015); Missing Information (4053)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported when using the bd cup urin ce, the device experienced missing label information.The following information was provided by the initial reporter.The customer stated: sticker label on top of urine cup dislodged/peeling off and user reached into box to grab a urine cup and sustained a needle stick injury.Sample is not available, destroyed by customer.Additionally they do not recall the batch number of the affected quantity.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 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.

Manufacturer Narrative

H.6.Investigation summary: no samples or photos were returned by the customer in support of this complaint from catalog 364941, lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.H3 other text : see h.10.

Event Description

It was reported when using the bd cup urin ce, the device experienced missing label information.The following information was provided by the initial reporter.The customer stated: sticker label on top of urine cup dislodged/peeling off and user reached into box to grab a urine cup and sustained a needle stick injury.Sample is not available, destroyed by customer.Additionally they do not recall the batch number of the affected quantity.

• Brand Name: BD CUP URIN CE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15544726
• MDR Text Key: 305891739
• Report Number: 2243072-2022-01725
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364941
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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