MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® BRAND PRONTO¿ QUICK RELEASE NEEDLE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368872

Device Problem Inaccurate Information (4051)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this.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.

Event Description

On the order (b)(4) received today, we have obviously received outdated items.The asn mentions this information: holder standard yellow b (4 sachets of 250) in a box (bx) (364879) - ddp 31/12/25.Pronto reusable self-picking body (box of 20) (368872) - 31/12/99.Can you please confirm the actual expiry dates? also, can you confirm that the use of these references is safe?.

Event Description

On the order ch_00099221 - etp062579 received today, we have obviously received outdated items (see pictures).The asn mentions this information: holder standard yellow b (4 sachets of 250) in a box (bx) (364879) - ddp 31/12/25 pronto reusable self-picking body (box of 20) (368872) - 31/12/99 can you please confirm the actual expiry dates? also, can you confirm that the use of these references is safe?.

Manufacturer Narrative

This complaint was deemed "not reportable" as this is a customer service issue.This product does not have an expiration date.The date printed on the label is the date of manufacture.No product defect alleged.

• Brand Name: BD VACUTAINER® BRAND PRONTO¿ QUICK RELEASE NEEDLE HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15781304
• MDR Text Key: 307671829
• Report Number: 2243072-2022-01931
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368872
• Device Lot Number: 22F23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• 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