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 Problem Break (1069)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

E.4 initial reporter phone#: (b)(6).E.7 initial reporter addr 1: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.

Event Description

It was reported that while using the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes that it was broken.The following information was provided by the initial reporter: damaged tube with black rubber.(1 pack).17-mar-2023- rcc reviewed photo- top of the tube cap shown to be damage with black rubber showing.

Manufacturer Narrative

The following fields have been corrected: d.1 medical device type: jka d.3.Medical device manufacturer: becton, dickinson & co.- broken bow, ne / 68822 d.4 medical device lot #: 2259054 d.4.Medical device expiration date: 31-dec-2023 d.4 medical device serial #: na g.1 manufacturing location: becton, dickinson & co.- broken bow, ne / 68822 g.5.Pma / 510(k)#: bk050036 h.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for defective product (improper assembly) was observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of improper assembly was not 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 improper assembly.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported that while using the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes that it was broken.The following information was provided by the initial reporter: damaged tube with black black rubber.(1 pack) 17-mar-2023- rcc reviewed photo- top of the tube cap shown to be damage with black rubber showing.

Event Description

It was reported that while using the bd vacutainer® k2 edta (k2e) 3.6mg blood collection tubes that it was broken.The following information was provided by the initial reporter: damaged tube with black black rubber.(1 pack) (b)(6) 2023- rcc reviewed photo- top of the tube cap shown to be damage with black rubber showing.

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes d.10 returned to manufacturer on: 12-may-2023 h.6.Investigation summary: bd received [100] samples and [1] photo for investigation.Visual examination of the samples and photo was performed and revealed improper assembly.Additionally, the customer samples along with [100] retention samples from bd inventory, were inspected with no issues being identified.Bd was able to confirm the customer¿s indicated failure mode with the samples and photo 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 process and final inspections comply with specification requirements.See h.10.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16686760
• MDR Text Key: 313537615
• Report Number: 2243072-2023-00564
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678414
• UDI-Public: 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2023

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: 12/31/2023
• Device Model Number: 367841
• Device Catalogue Number: 367841
• Device Lot Number: 2259054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/14/2023; 05/19/2023
• Supplement Dates FDA Received: 04/21/2023; 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1