MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309653

Device Problem Leak/Splash (1354)

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

Event Date 12/10/2019

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 during use there was leakage past the stopper with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, translated from (b)(6) to english: new 60 ml syringes leak past stopper, it happened more times.

Manufacturer Narrative

H.6.Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.While a definitive root cause could not be determined, leakage can be caused by the interaction between the barrel inside diameter, the stopper outside diameter, and plunger rod bayonet outside diameter and forces applied during use.The syringe is more likely to leak when forces are applied to the plunger rod when fully extended.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.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.H3 other text : see section h.10.

Event Description

It was reported that during use there was leakage past the stopper with a bd 60ml syringe luer-lok¿ tip.The following information was provided by the initial reporter, translated from dutch to english: new 60 ml syringes leak past stopper, it happened more times.

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9527199
• MDR Text Key: 193665635
• Report Number: 1911916-2019-01341
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• 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: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 9240040
• Date Manufacturer Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other