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

Catalog Number 367300

Device Problems Fluid/Blood Leak (1250); Microbial Contamination of Device (2303)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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.".

Event Description

It was reported that bd vacutainer® multiple sample luer adapter had blood leakage.The following information was provided by the initial reporter: "la separates when removing the vacutainer ".

Manufacturer Narrative

Correction: b2: adverse type: product problem.B2: event attributed to: na.B5: describe event or problem: it was reported that bd vacutainer® multiple sample luer adapter had blood leakage.The following information was provided by the initial reporter: "la separates when removing the vacutainer" h2: type of reportable events: malfunction.H5: imdrf annex a grid: a050401.The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-14.H6: investigation summary: the sample for lot number 1174667 was evaluated by visual examination for damaged or missing parts with no defects observed as the device appeared to be correctly assembled.Ten (10) retention samples were evaluated by functional testing and no defects were observed.The sample of an unknown lot was evaluated by visual examination and a side pierced sleeve was observed with leakage in the holder of the device.

• 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: 12870986
• MDR Text Key: 281224190
• Report Number: 1024879-2021-00827
• 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: 01/20/2022

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: 1174667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• 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: 01/18/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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