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

Model Number 309649

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Description

It was reported that "moisture/condensation" was found in the bd syringe luer-lok¿ tip before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "unfortunately, these cannot be used due to moisture/condensation formation in the syringe.".

Event Description

It was reported that "moisture/condensation" was found in the bd syringe luer-lok¿ tip before use.The following information was provided by the initial reporter, translated from dutch to english: "unfortunately, these cannot be used due to moisture/condensation formation in the syringe.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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 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: 9525921
• MDR Text Key: 193666474
• Report Number: 1213809-2019-01310
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• 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: 02/25/2020

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: 309649
• Device Catalogue Number: 309649
• Device Lot Number: 9200382
• 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: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other