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

Model Number 366430

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported with the use of the bd vacutainer® serum blood collection tubes there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.

Manufacturer Narrative

H6 investigation: a review of the device history record was completed for this batch 0156058.All inspections were in compliance with requirements.There were no qns or ncmrs associated with this batch.Bd sumter received 10 bd luer adapter devices.The samples were subjected to a torque force test in order to test the hub strength.All 10 samples passed the test and met specification requirements.The minimum force required to break the hub as stated in vs50004 is 2.5lbs.The 10 samples tested with forces ranging from 2.95-5.16lbs.Based on the customer samples and investigation results, bd is unable to confirm the customer¿s reported failure mode of a broken device as we were unable to duplicate the reported failure mode.

Event Description

It was reported with the use of the bd vacutainer® serum blood collection tubes there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.

Event Description

It was reported with the use of the bd vacutainer® multiple sample luer adapter there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.

Manufacturer Narrative

The following fields have been corrected: b5.Describe event or problem: it was reported with the use of the bd vacutainer® multiple sample luer adapter there was an adverse event without identified device or use problem.The following information was provided by the initial reporter.The customer stated "the adapter broke off inside the lumen.A user facility dialysis technician reported that the adapter broke off inside of the lumen.All attempts to remove it only broke it down even further." patient had to be sent to the er for evaluation of central venous catheter (cvc).Cvc was ultimately replaced by surgeon.D1: medical device brand name: bd vacutainer® multiple sample luer adapter d2a: common device name: blood specimen collection device d2b: medical device type or (procode) : jka.D4 catalog #: 367290.D4.Medical device lot#: 0156058.D4 udi: (b)(4).G5.Pma/510k info: k991088.D4.Medical device expiration date: 31-may-2023.H4.Device manufacture date: 04-jun-2020.H6.Investigation summary: bd received ten (10) samples for investigation.The samples were evaluated by functional testing and the indicated failure mode for damaged with the incident lot was not observed as all product specifications were met.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 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.

• Brand Name: BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 10907373
• MDR Text Key: 218667296
• Report Number: 1917413-2020-01185
• 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,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: 366430
• Device Catalogue Number: 367290
• Device Lot Number: 0156058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 01/21/2021; 04/10/2023
• Supplement Dates FDA Received: 01/21/2021; 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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): Other