MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367352
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one bd vacutainer® push button blood collection set with pre-attached holder has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it is reported needle broke during blood collection.Verbiage received, - bd vacutainer set with reattached holder containing 21g x 3/4 inch x 12 inch butterfly attachment lot #8323548, exp 11/30/2020: during venipuncture the needle (metal portion) broke off and had to be retrieved from entrance to vein with forceps.Metal portion of vacutainer removed intact.Pt had brief syncopal response to this event.Pt declined ultrasound to assess for any remaining foreign body.Pt reports no symptoms other than mild bruise at site of veinpuncture, states that he feels well on f/u call.Product discarded into sharps container at the time of the event.
Additional Manufacturer Narrative
H.6.Investigation: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for breaks off with the incident lot was not observed as all product specifications were met.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.
Event or Problem Description
It has been reported that one bd vacutainer® push button blood collection set with pre-attached holder has been found with the cannula breaking off during use.The following has been provided by the initial reporter: it is reported needle broke during blood collection.Verbiage received, bd vacutainer set with reattached holder containing 21g x 3/4 inch x 12 inch butterfly attachment lot #8323548, exp 11/30/2020: during venipuncture the needle (metal portion) broke off and had to be retrieved from entrance to vein with forceps.Metal portion of vacutainer removed intact.Pt had brief syncopal response to this event.Pt declined ultrasound to assess for any remaining foreign body.Pt reports no symptoms other than mild bruise at site of veinpuncture, states that he feels well on f/u call.Product discarded into sharps container at the time of the event.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 9775026
• Report Number: 1024879-2020-00148
• Device Sequence Number: 526675
• Product Code: FPA
• UDI-Device Identifier: 50382903673525
• UDI-Public: 50382903673525
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: 367352
• Device Catalogue Number: 367352
• Device Lot Number: 8323548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other