MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 367344

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Medical device type: jka, fpa.Device expiration 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.Device manufacture date: unknown.

Event Description

It was reported that the bd vacutainer® push button blood collection set caused a serious injury in the form of a dirty needle stick after use.The following information was provided by the initial reporter: phlebotomist sustained a needle stick injury with a push button blood collection set, as they did not activate the safety mechanism immediately following collection.Unfortunately the patient is positive to a communicative disease so the staff member will be receiving treatment.

Manufacturer Narrative

Investigation: 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 potential incident lots provided 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.

Event Description

It was reported that the bd vacutainer® push button blood collection set caused a serious injury in the form of a dirty needle stick after use.The following information was provided by the initial reporter: phlebotomist sustained a needle stick injury with a push button blood collection set, as they did not activate the safety mechanism immediately following collection.Unfortunately the patient is positive to a communicative disease so the staff member will be receiving treatment.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8833529
• MDR Text Key: 152485077
• Report Number: 1024879-2019-01259
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673440
• UDI-Public: 50382903673440
• Combination Product (y/n): N
• PMA/PMN Number: K030573
• 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: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 367344
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other