MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367326
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: intravascular administration set, medical device type: fpa.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported before use the bd vacutainer® push button blood collection set had failure of product to contain blood/medication (i.E crack or hole in the syringe, cut, etc).The following information was provided by the initial reporter: the customer stated the "device was found to have a defective connector and tubing.The product was rejected in our production line by an operator.".
Additional Manufacturer Narrative
H.6.Investigation: received one (1) unused pbbcs unit from ref.(b)(4), lot 8354645.One (1) sample photo was submitted for evaluation which displayed a pbbcs unit.A visual / microscopic evaluation was performed on the returned sample.White foreign matter was observed on the outside tubing has it attached to the female luer connector.The foreign matter was determined to be a piece of terry wipe with adhesive residue.Based on the evaluation of the submitted photos, similar findings to that of the returned unit were in common.The defect tubing damage was confirmed.Based on a review of the device history record for the incident lot, 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.
Event or Problem Description
It was reported before use the bd vacutainer® push button blood collection set had failure of product to contain blood/medication (i.E crack or hole in the syringe, cut, etc).The following information was provided by the initial reporter: the customer stated the "device was found to have a defective connector and tubing.The product was rejected in our production line by an operator.".

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10561081
• Report Number: 1710034-2020-00597
• Device Sequence Number: 436415
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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
• Report Date (Section B): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2020
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 8354645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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