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

Catalog Number 367300

Device Problems Short Fill (1575); Microbial Contamination of Device (2303)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd vacutainer® multiple sample luer adapter a patient got infected and required medical intervention.The following information was provided by the initial reporter: "- an infection".

Manufacturer Narrative

Correction: the following fields were corrected: b2: adverse type: product problem b5: describe event or problem: it was reported that bd vacutainer® multiple sample luer adapter had insufficient blood flow.The following information was provided by the initial reporter: "placement of my adapter with vacutainer for blood sampling.No venous return, unable to draw blood" h2: type of reportable events: malfunction h5: imdrf annex a grid: a140303 investigation summary the luer adapter iv and np shields for lot number 1081842 could not be evaluated for the indicated failure mode because the luer adapter assembly was not provided.Therefore, ten (10) retention samples were evaluated by functional testing and no defects related to insufficient flow were observed.

Event Description

It was reported that bd vacutainer® multiple sample luer adapter had insufficient blood flow.The following information was provided by the initial reporter: "placement of my adapter with vacutainer for blood sampling.No venous return, unable to draw blood".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12870992
• MDR Text Key: 285945028
• Report Number: 1024879-2021-00825
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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 Catalogue Number: 367300
• Device Lot Number: 1081842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/26/2022
• 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
• Patient Outcome(s): Required Intervention