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

Catalog Number 367300

Device Problems Microbial Contamination of Device (2303); Missing Information (4053)

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

Event Date 01/25/2021

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: b2: adverse type: product problem b5: describe event or problem: it was reported that bd vacutainer® multiple sample luer adapter had missing label information.The following information was provided by the initial reporter: "writing getting smaller and smaller, very difficult to read the expiry date." h2: type of reportable events: malfunction h5: imdrf annex a grid: a210105 h5: imdrf annex g grid g04080 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 bd received four (4) samples for investigation.The sample for lot number 0239524 was evaluated by visual examination and the indicated failure mode for illegible lot number with the incident lot was observed.(b)(4) retention samples from bd inventory were evaluated by visual examination and the issue of illegible lot number was observed.The device history record was reviewed for the known lots with no issues being identified.This complaint has been confirmed for the indicated failure modes of illegible information.Bd determined that the root cause of the illegible lot was attributed to insufficient mica resin ratio.Corrective actions were taken to increase the font size, decrease the print speed, and fully service the printing laser.

Event Description

It was reported that bd vacutainer® multiple sample luer adapter had missing label information.The following information was provided by the initial reporter: "writing getting smaller and smaller, very difficult to read the expiry date.".

• 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: 12870983
• MDR Text Key: 281270548
• Report Number: 1024879-2021-00828
• 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

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367300
• Device Lot Number: 0239524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• 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