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

Catalog Number 364975

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that bd vacutainer® urine collection cups are being used and causing needlestick injuries from the lid.This occurred on 5 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.364975, batch no.Unknown.It was reported that several patients are getting needlesticks from the lid of the bd urine collection cup.An employee and several patients are getting needlesticks from the lid of the bd urine collection cup.Instructions were given to patients to just open the cup and collect urine specimen but they still get stuck with the needle.The picture of the finger on the sticker makes the patient think they need to stick their finger in the hole.There were 4 patients and 1 employee incidents of needlesticks.Customer did not directly inform me of the issue.It was only brought up when i asked how the implementation was going.They are now just giving regular cups to patient if the service representative feel that they are not getting through to the patient or if there is a language barrier.

Event Description

It was reported that bd vacutainer® urine collection cups are being used and causing needlestick injuries from the lid.This occurred on 5 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no.364975, batch no.Unknown.It was reported that several patients are getting needlesticks from the lid of the bd urine collection cup.An employee and several patients are getting needlesticks from the lid of the bd urine collection cup.Instructions were given to patients to just open the cup and collect urine specimen but they still get stuck with the needle.The picture of the finger on the sticker makes the patient think they need to stick their finger in the hole.There were 4 patients and 1 employee incidents of needlesticks.Customer did not directly inform me of the issue.It was only brought up when i asked how the implementation was going.They are now just giving regular cups to patient if the service representative feel that they are not getting through to the patient or if there is a language barrier.

Manufacturer Narrative

Investigation summary: 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.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.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.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUPS
• Type of Device: SPECIMEN TRANSPORT & STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8856279
• MDR Text Key: 153135298
• Report Number: 1917413-2019-01861
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• 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: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other