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	07/22/2020
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.(b)(4).
Event or Problem Description
It was reported that bd vacutainer push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "the customer found that the tubing was partly damaged.Bd is required to replace the complaint product and submit a closure letter about the cause(s).".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but three (3) photos were provided by the customer for investigation.The defect of damaged (tubing) as stated, was not confirmed.Instead, the investigation has confirmed the extension tubing has adhesive in the area below the luer adapter.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.Bd has initiated further root cause investigation relating to the issue of damaged through a corrective and preventive action (capa) 1172284.H3 other text : see h.10.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "the customer found that the tubing was partly damaged.Bd is required to replace the complaint product and submit a closure letter about the cause(s).".

• 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: 10417965
• Report Number: 1710034-2020-00518
• Device Sequence Number: 2949203
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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: 03/31/2021
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 9088545
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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