MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

Catalog Number 367364

Device Problem Product Quality Problem (1506)

Patient Problems Bruise/Contusion (1754); Needle Stick/Puncture (2462)

Event Date 04/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.No lot # provided.Medical device expiration date: unknown.(b)(4).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 that during use a bd vacutainer® ultratouch¿ push button blood collection set.Malfunctioned as the safety device failed as "while performing venipuncture during the ultratouch push button vacutainer blood collection set, the needle retracted while still drawing blood.The tourniquet was still in place therefore the patient was bleeding from the site and started to bruise".A second event occured with this product where injury occured as "after obtaining lab work from patient i went to pick up the butterfly needle that was used to put in the sharps container.I am not sure how, but the needle punctured my left middle finger.To note, when i was obtaining patient's labs, the safety feature on the needle went off while the needle was in the patient's vein.Even though i had not pushed the button.The labs had not been obtained yet so i had to get another needle to obtain the labs".There was no further report of medical intervention given for needle stick.

Manufacturer Narrative

Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: 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® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7527626
• MDR Text Key: 108995837
• Report Number: 1024879-2018-00208
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673648
• UDI-Public: 50382903673648
• Combination Product (y/n): N
• PMA/PMN Number: K153309
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367364
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other