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

Catalog Number	367323
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: fpa.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd vacutainer® push button blood collection set the was an issue with leakage at the level of the tubing.This occurred on 5 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from (b)(6) to english: "when setting up the wing for the injection of radioactive product, a leakage in the tubing was found.Fortunately there was no consequence of radioactive contamination because tubing was purged with saline.On the other hand, there was an obligation to puncture the patient again in order to administer the contrast product.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.
Event or Problem Description
It was reported that during use of the bd vacutainer® push button blood collection set the was an issue with leakage at the level of the tubing.This occurred on 5 separate occasions but the date/time and or patient information is unknown.The following information was provided by the initial reporter, translated from french to english: "when setting up the wing for the injection of radioactive product, a leakage in the tubing was found.Fortunately there was no consequence of radioactive contamination because tubing was purged with saline.On the other hand, there was an obligation to puncture the patient again in order to administer the contrast product.".

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9157729
• Report Number: 1710034-2019-01082
• Device Sequence Number: 11295739
• Product Code: JKA
• UDI-Device Identifier: 50382903673235
• UDI-Public: 50382903673235
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 10/22/2019

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: 10/31/2020
• Device Catalogue Number: 367323
• Device Lot Number: 8292556
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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