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

Model Number 309658

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd plastipak¿ syringe luer-lok¿ tip leaked from between the syringe and needle.The following information was provided by the initial reporter, translated from (b)(6) to english: "complaints are reported from the anesthesiologists, the connection between the syringe and the needle is leaking.".

Event Description

It was reported that the bd plastipak¿ syringe luer-lok¿ tip leaked from between the syringe and needle.The following information was provided by the initial reporter, translated from dutch to english: "complaints are reported from the anesthesiologists, the connection between the syringe and the needle is leaking.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.

• Brand Name: BD PLASTIPAK 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: 11388525
• MDR Text Key: 233967200
• Report Number: 1213809-2021-00112
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096580
• UDI-Public: 30382903096580
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309658
• Device Catalogue Number: 309658
• Device Lot Number: 0206893
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1