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

Catalog Number 367364

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® ultratouch¿ push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "this is a report about a deformed and cracked tubing of wingset pbbcs.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/17/2021.H.6.Investigation: seven photos as well as 1 contaminated physical sample were received for review and evaluation.The photos and sample were evaluated and the customer's indicated failure mode of cut (cracked) tubing was observed.Batch number: unknown (lot 1174674 provided but appears to be incorrect based on physical sample, wing marking indicates a different product line) in addition, 30 retention samples from lot 1174674 were subjected to a submerged leak test as well as a visual for cut tubing.All samples passed the tests with no defects observed.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Bd is able to confirm the customer¿s reported failure from the customer sample and photos received as we were able to duplicate the customer¿s reported failure mode.The root cause of the cut tubing is attributed to the packaging process.H3 other text : see h.10.

Event Description

It was reported that bd vacutainer® ultratouch¿ push button blood collection set failed to contain blood or medication.The following information was provided by the initial reporter: "this is a report about a deformed and cracked tubing of wingset pbbcs.".

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Type of 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12913766
• MDR Text Key: 281584905
• Report Number: 1024879-2021-00830
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903673648
• UDI-Public: 382903673648
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 367364
• Device Lot Number: 1174674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1