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	09/17/2020
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: medical device type: fpa.Common device name: intravascular administration set.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that prior to use with 20 bd vacutainer® push button blood collection set the tubing was damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer found a damaged tubing before use.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but eight [8] photos were provided by the customer for investigation.Based on the observation of the photos; it is concluded that the retracted needles and bent tubing of these unused units is evident of premature retraction inside the packaging.Because the lever arm of the units cannot be viewed, it cannot be concluded if they are damaged.Hence, that a broken lever arm can contribute to premature retraction.The provided photos disclose sufficient evidence to confirm preactivation with bent extension tubing.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.
Event or Problem Description
It was reported that prior to use with 20 bd vacutainer® push button blood collection set the tubing was damaged.The following information was provided by the initial reporter, translated from japanese to english: the customer found a damaged tubing before use.

• 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: 10645445
• Report Number: 1710034-2020-00648
• Device Sequence Number: 571755
• 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): 10/28/2020

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: 9086536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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