MAUDE Adverse Event Report: BECTON DICKINSON 25 GUAGE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Microbial Contamination of Device (2303)

Patient Problem Inflammation (1932)

Event Date 01/14/2023

Event Type  Injury  

Event Description

It was reported by the customer that the customer experienced having an infection complication while using an unspecified 25 guage bd vacutainer® safety-lok¿ blood collection set.Verbatim: a post market surveillance was conducted for safety lok blood collection sets as was required by the notified body for eu mdr ce mark and an infection complication was reported.Steps taken with customer/troubleshooting: the responder identifier is number (b)(6) with a procedure date of (b)(6) 2023.Customer is family medicine.A 25 gauge safety lok blood collection set was used connected to a infusion device.No additional information as customer requests to remain anonymous.

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in report and the franklin lakes fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Adverse event problem investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.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: 25 GUAGE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• 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 ; 8448235433
• MDR Report Key: 16718581
• MDR Text Key: 313150494
• Report Number: 2243072-2023-00597
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• 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
• Patient Outcome(s): Other