MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367841

Device Problems Nonstandard Device (1420); Short Fill (1575)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes were received with misaligned gemogard cap and they exhibited underfilling when used.Verbatim: a report was received on 86 pieces of 367841 tubes from multiple shelf packs with misaligned hemogard cap relative to the rubber stopper.The exact number of shelf pack affected is not documented.The said affected tubes were also presumed to have low vacuum as demonstrated by underfilling when used during collection.The affected tubes were found in collection site.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: bd received eighty-six (86) samples and four (4) photos for investigation.Visual examination of the samples was performed and revealed improper assembly.The photos were evaluated and underfill and improper assembly was observed.Additionally, ten (10) customer samples along with ten (10) retention samples from bd inventory, were evaluated by functional testing and the issue of underfill was not observed.An additional one hundred (100) retention samples were visually inspected with no issues being identified."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.Bd was able to confirm the customer¿s indicated failure modes of improper assembly with the samples and photos provided, underfill was seen in the photos; however, not seen in the sample testing.The following fields were updated due to additional information: d9: device available for evaluation:  yes d9: returned to manufacturer on: 2023-06-13.

Event Description

It was reported that bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes were received with misaligned gemogard cap and they exhibited underfilling when used.Verbatim: a report was received on 86 pieces of 367841 tubes from multiple shelf packs with misaligned hemogard cap relative to the rubber stopper.The exact number of shelf pack affected is not documented.The said affected tubes were also presumed to have low vacuum as demonstrated by underfilling when used during collection.The affected tubes were found in collection site.

• Brand Name: BD VACUTAINER® K2 EDTA (K2E) 3.6MG BLOOD COLLECTION TUBES
• 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: 17125974
• MDR Text Key: 317160610
• Report Number: 1917413-2023-00541
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678414
• UDI-Public: (01)50382903678414
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: BK050036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 367841
• Device Catalogue Number: 367841
• Device Lot Number: 2166018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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