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

Model Number 367001

Device Problems Break (1069); Crack (1135)

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

Event Date 04/10/2023

Event Type  malfunction  

Event Description

It was reported that during use with 28 bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg the tubes broke while in the freezer.Samples were from post-mortem patients.The following information was provided by the initial reporter: customer reports that 28 out of last 32 specimens have broken while in the -30c freezer.

Manufacturer Narrative

D.1.Medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 7 photos were provided for investigation.The photos were reviewed and the indicated failure mode for cracked product was observed.The customer states that the tubes were frozen to temperatures of -30c.The instructions for use on the evacuated blood collection system states under the storage for the product, ¿store tubes at 4-25°c (39-77°f).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 cracked product 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 during use with 28 bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg the tubes broke while in the freezer.Samples were from post-mortem patients.The following information was provided by the initial reporter: customer reports that 28 out of last 32 specimens have broken while in the -30c freezer.

Manufacturer Narrative

The following fields were corrected due to additional information: annex a code: a0404.B.5.Describe event or problem: it was reported that during use with 28 bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg the tubes cracked/broke while in the freezer.Samples were from post-mortem patients.The following information was provided by the initial reporter: customer reports that 28 out of last 32 specimens have broken while in the -30c freezer.

Event Description

It was reported that during use with 28 bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg the tubes cracked/broke while in the freezer.Samples were from post-mortem patients.The following information was provided by the initial reporter: customer reports that 28 out of last 32 specimens have broken while in the -30c freezer.

• 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: 16841508
• MDR Text Key: 314272312
• Report Number: 1917413-2023-00357
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: (01)50382903670012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901449
• 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,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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