MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367324
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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
It was reported when using the bd vacutainer® push button blood collection set customer reports that they've found crushed and thin tubes.The following information was provided by the initial reporter.The customer stated: the customer reported that the product (wingset 23g) found with crushed and thinned tubing.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set customer reports that they've found crushed and thin tubes.The following information was provided by the initial reporter.The customer stated: the customer reported that the product (wingset 23g) found with crushed and thinned tubing.
Additional Manufacturer Narrative
The following fields were updated with additional information: d.10 device available for eval? yes, d.10 returned to manufacturer on: 17-aug-2023.H.6.Investigation summary: bd received 1 sample for investigation.The sample was evaluated by visual examination and the indicated failure mode for cut tubing was observed.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint has been confirmed for the indicated failure mode cut tubing.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17560449
• Report Number: 1024879-2023-00580
• Device Sequence Number: 3584176
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: 50382903673242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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 Catalogue Number: 367324
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown