MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Model Number 309570

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.: 309570 batch no.: 9057820.It was reported that before use of the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle the customer experienced issues with the luer part on the holder either broken off, cracked or the needle was missing out of the package.The following information was provided by the initial reporter: we've been having issues with our syringe/needle combo for the last year with the needle luer part on holder either broken off, cracked, or missing the needle out of the package all together.We have been using the product for over 35 years and the last years it seems the quality is lower.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

Material no.: 309570 batch no.: 9057820.It was reported that before use of the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle the customer experienced issues with the luer part on the holder either broken off, cracked or the needle was missing out of the package.The following information was provided by the initial reporter: we've been having issues with our syringe/needle combo for the last year with the needle luer part on holder either broken off, cracked, or missing the needle out of the package all together.We have been using the product for over 35 years and the last years it seems the quality is lower.".

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9526216
• MDR Text Key: 193668482
• Report Number: 1213809-2019-01311
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: 30382903095705
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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 Expiration Date: 01/31/2024
• Device Model Number: 309570
• Device Catalogue Number: 309570
• Device Lot Number: 9057820
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other