MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367962

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd vacutainer® pst¿ gel and lithium heparinn (lh) 83 units blood collection tubes initial reporter state: address information was not able to be obtained, therefore, nj was used as a place holder.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 that prior to use with bd vacutainer® pst¿ gel and lithium heparinn (lh) 83 units blood collection tubes the cap was dented.The following information was provided by the initial reporter: customer reports dented cap for cat 367962 lot 2259094.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for molding defect was observed.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 issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode molding defect based on photos only.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported that prior to use with bd vacutainer® pst¿ gel and lithium heparinn (lh) 83 units blood collection tubes the cap was dented.The following information was provided by the initial reporter: customer reports dented cap for cat 367962, lot 2259094.

• Brand Name: SEE H.10
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17054586
• MDR Text Key: 317584427
• Report Number: 1917413-2023-00483
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679626
• UDI-Public: (01)50382903679626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 367962
• Device Catalogue Number: 367962
• Device Lot Number: 2259094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/02/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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