MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD URINE COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: 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 a needle stick occurred with a unspecified bd urine cup.The following information was provided by the initial reporter, "material no.Unknown batch no.Unknown.It was reported that an employee sustain a needle stick with the vacutainer as she was peeling back the sticker.We had an employee sustain a needlestick with the vacutainer as she was peeling back the sticker.The product insert states that the ¿needle¿ is an ¿integrated transfer device¿.Can ¿touch¿ alone can active the suction of urine up the needle, or does the ¿negative pressure¿ (aka vacuum) needs to be applied for the urine to flow upwards.We are trying to determine if the nurse had any potential of exposure of urine and/or if there was any chance of the nurse¿s blood contaminating the patient¿s urine sample.Work order notes: on 04/15/19 sent an email requesting that the customer contact me, as there was no telephone number provided.On 04/22/19 sent a 2nd email to the customer.On 04/23/19 the customer called back and stated that the incident occurred when a nurse peeled back the label on the top of the urine cup and stuck her finger in the unused needle.The customer indicated that it was a 'clean needle stick.' she stated that it was 'dumb, user error.' i called her back to request some follow up information.On 04/23/19 the customer called back and stated that the needle stick injury was to the nurse's thumb as she peeled the label back.The nurse went to employee occupational health service as per their protocol, and received a medical evaluation.They determined that there was no blood or body fluid exposure, and there was no follow up treatment, and the nurse returned to work.".

Manufacturer Narrative

Investigation summary: bd had made multiple attempts to reach the customer in order to gather more information on the catalog and lot number; however, this was not provided by the customer.A good faith effort has been made and this complaint will be closed without further investigation at this time.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Bd technical services conducted follow up with the customer to gather more information on the incident.The customer indicated that the issue was attributed to user error.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that a needle stick occurred with a unspecified bd urine cup.The following information was provided by the initial reporter, "material no.Unknown; batch no.Unknown.It was reported that an employee sustain a needle stick with the vacutainer as she was peeling back the sticker.We had an employee sustain a needlestick with the vacutainer as she was peeling back the sticker.The product insert states that the ¿needle¿ is an ¿integrated transfer device¿.Can ¿touch¿ alone can active the suction of urine up the needle, or does the ¿negative pressure¿ (aka vacuum) needs to be applied for the urine to flow upwards.We are trying to determine if the nurse had any potential of exposure of urine and/or if there was any chance of the nurse¿s blood contaminating the patient¿s urine sample.Work order notes: on 04/15/2019 sent an email requesting that the customer contact me, as there was no telephone number provided.On 04/22/2019 sent a 2nd email to the customer.On (b)(6) 2019 the customer called back and stated that the incident occurred when a nurse peeled back the label on the top of the urine cup and stuck her finger in the unused needle.The customer indicated that it was a "clean needle stick." she stated that it was "dumb, user error." i called her back to request some follow up information.On (b)(6) 2019 the customer called back and stated that the needle stick injury was to the nurse's thumb as she peeled the label back.The nurse went to employee occupational health service as per their protocol, and received a medical evaluation.They determined that there was no blood or body fluid exposure, and there was no follow up treatment, and the nurse returned to work.".

• Brand Name: UNSPECIFIED BD URINE COLLECTION DEVICE
• Type of Device: URINE COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8562736
• MDR Text Key: 143583187
• Report Number: 2243072-2019-00810
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention