MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367336

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2059667, medical device expiration date: 2024-02-29, device manufacture date: 2022-02-28; medical device lot #: 2136675, medical device expiration date: 2024-05-31, device manufacture date: 2022-05-16; medical device lot #:2150907, medical device expiration date: 2024-05-31, device manufacture date: 2022-05-30.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced a damaged or open unit package where sterility is compromised.This event occurred 8 times with lot 2059667.This event occurred 4 times with lot 2136675.This event occurred 6 times with lot 2150907.The following information was provided by the initial reporter.The customer stated: we complained that the capsule packages were found deformed.There is uncertainty about safety in terms of sterilization and its application.

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced a damaged or open unit package where sterility is compromised.This event occurred 8 times with lot: 2059667.This event occurred 4 times with lot: 2136675.This event occurred 6 times with lot: 2150907.The following information was provided by the initial reporter.The customer stated: we complained that the capsule packages were found deformed.There is uncertainty about safety in terms of sterilization and its application.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the original manufacturing location was incorrectly filed.Please see the changes below.D.3.Manufacturing location: becton, dickinson and company (bd).G.1.Manufacturing location: becton, dickinson and company (bd).

Event Description

It was reported when using the bd vacutainer® push button blood collection set, the device experienced a damaged or open unit package where sterility is compromised.This event occurred 8 times with lot: 2059667.This event occurred 4 times with lot: 2136675.This event occurred 6 times with lot: 2150907.The following information was provided by the initial reporter.The customer stated: we complained that the capsule packages were found deformed.There is uncertainty about safety in terms of sterilization and its application.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-10-31.H.6.Investigation summary: bd received 44 samples from lot 2136675), 8 samples from lot 2059667) and 8 samples from lot 2150907 and 4 photos from the customer in support of this complaint.An evaluation of the returned samples and photos was performed, and the issue of deformed packaging was observed.Additionally, 50 retained samples from each lot number of the bd inventory provided were visually inspected, and no deformed packaging was found.Bd was able to confirm the customer¿s indicated failure mode because the defect was evident in the photos and samples provided.Bd was not able to identify a root cause for the indicated failure mode.The device history records were reviewed with no issues being identified.There were no related quality notifications.All processes and final inspections comply with specification requirements.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth SC ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth SC ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15615915
• MDR Text Key: 303553717
• Report Number: 1024879-2022-00609
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903673365
• UDI-Public: 50382903673365
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K030573
• 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,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367336
• Device Catalogue Number: 367336
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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