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	368656
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: fmi/jka.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Material no.368656, material no.9150607.It is reported that during use of the bd vacutainer® push button blood collection set blood splatter was inside holder and leakage was witnessed under blue wings after blood draw was complete.The following information was provided by the initial reporter: "a drop of blood was noticed on the hub while being used.And when the needle was took out, blood was also noticed under the wings.".
Event or Problem Description
Material no.368656, material no.9150607.It is reported that during use of the bd vacutainer® push button blood collection set blood splatter was inside holder and leakage was witnessed under blue wings after blood draw was complete.The following information was provided by the initial reporter: "a drop of blood was noticed on the hub while being used.And when the needle was took out, blood was also noticed under the wings.".
Additional Manufacturer Narrative
G.4.Date received by manufacturer: 2019-10-11.
Event or Problem Description
Material no.368656, material no.9150607 it is reported that during use of the bd vacutainer® push button blood collection set blood splatter was inside holder and leakage was witnessed under blue wings after blood draw was complete.The following information was provided by the initial reporter: "a drop of blood was noticed on the hub while being used.And when the needle was took out, blood was also noticed under the wings.".
Additional Manufacturer Narrative
H.6.Investigation: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for leakage with the incident lot was not observed.Additionally, evaluation/testing of the customer samples was performed and leakage was not observed.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.H3 other text : see h.10.

• 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: 9233874
• Report Number: 1024879-2019-01854
• Device Sequence Number: 2238025
• Product Code: FMI
• UDI-Device Identifier: 50382903686563
• UDI-Public: 50382903686563
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2020

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: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 368656
• Device Catalogue Number: 368656
• Device Lot Number: 9150607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 10/11/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/27/2020; 01/29/2020
• 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