MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367290

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported when using the bd vacutainer® multiple sample luer adapter breaking during removal.3 of 3.The following information was provided by the initial reporter.The customer stated: customer problem: customer states luer adapter is breaking during removal.If exposure occurred was there any post exposure testing or medical intervention? patient number one was transported to the er by his wife.(1 of 3).Patient number 2 had to be transported to er by non-emergent ambulance.(2 of 3).For patient number 3, the leur adapter broke off inside the end of their fistula needle.Rather than using the fistula, the patient was changed over to her catheter for her treatment.Nothing further was needed for patient number 3.(3 of 3).

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported when using the bd vacutainer® multiple sample luer adapter breaking during removal.3 of 3 the following information was provided by the initial reporter.The customer stated: customer problem: customer states luer adapter is breaking during removal.If exposure occurred was there any post exposure testing or medical intervention? patient number one was transported to the er by his wife.(1 of 3).Patient number 2 had to be transported to er by non-emergent ambulance.(2 of 3).For patient number 3, the leur adapter broke off inside the end of their fistula needle.Rather than using the fistula, the patient was changed over to her catheter for her treatment.Nothing further was needed for patient number 3.(3 of 3).

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-07-07.H.6.Investigation summary: bd received ninety-five (95) samples and one (1) photo for investigation.The photo was reviewed and the indicated failure mode for broken adapter with the incident lot was not observed.Sixty-six (66) of the customer samples were randomly selected and evaluated by visual examination.No issues were observed relating to broken adapter as all samples met specifications.Sixty (60) of the customer samples were randomly selected and evaluated by functional testing.No issues were observed relating to broken adapter as all samples met specifications.Additionally, thirty (30) retention samples from bd inventory, were evaluated by functional testing and no issues were observed relating to broken adapter as all samples met specifications.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 is unable to be confirmed for the indicated failure mode of broken adapter.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.".

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15009225
• MDR Text Key: 295857011
• Report Number: 1024879-2022-00365
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903672900
• UDI-Public: 50382903672900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 367290
• Device Catalogue Number: 367290
• Device Lot Number: 1333247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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
• Patient Outcome(s): Required Intervention