MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309628

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).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.(b)(4).

Event Description

It was reported that the patient had an allergic reaction to the bd syringe luer-lok tip.The following information was provided by the initial reporter: "item bd sr 1ml luer lok tip 309628, we had an issue with a patient reaction.".

Manufacturer Narrative

Correction: after further review, the complaint was found to be a duplicate of another complaint that was deemed non-reportable.Therefore this complaint will be considered as non-reportable and will be cancelled.

Event Description

It was reported that the patient had an allergic reaction to the bd syringe luer-lok¿ tip.The following information was provided by the initial reporter: "item bd sr 1ml luer lok tip 309628, we had an issue with a patient reaction.".

• Brand Name: BD SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10833656
• MDR Text Key: 216113456
• Report Number: 1213809-2020-00794
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other