MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 1ML SYRINGE LUER-LOK¿ TIP; IRRIGATING SYRINGE

Model Number 309620

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 bd 1ml syringe luer-lok¿ tip leaked.This was discovered during use.The following information was provided by the initial reporter: material no.: 309620 batch no.: 9240843.It was reported that a unit that uses these syringes for filling feeding tubes were experiencing leakage from the seal at the bottom and from the tip.Per email: a unit that uses these for filling feeding tubes showed me today that they are leaking from the tip and the seal at the bottom of the syringe.

Manufacturer Narrative

H.6.Investigation: no samples or photos were received; therefore, sample analysis could not be performed and the conditions reported by the customer could not be confirmed.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that bd 1ml syringe luer-lok¿ tip leaked.This was discovered during use.The following information was provided by the initial reporter: material no.: 309620 batch no.: 9240843 it was reported that a unit that uses these syringes for filling feeding tubes were experiencing leakage from the seal at the bottom and from the tip.Per email: a unit that uses these for filling feeding tubes showed me today that they are leaking from the tip and the seal at the bottom of the syringe.

• Brand Name: BD 1ML SYRINGE LUER-LOK¿ TIP
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9520280
• MDR Text Key: 193652469
• Report Number: 1911916-2019-01326
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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 Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: 9240843
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other