MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ; PISTON SYRINGE

Catalog Number 309653

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the syringe 60 ml ll tip 1 ml 2 oz in 1/4 oz experienced leakage past the stopper/plunger during use.The following information was provided by the initial reporter: material no: 309653, batch no: 9029571.Description: we were compounded chemotherapy twice this week and had leakage using bd 60 ml luer lock syringes.In the first instance, august 26th the medication we were using leaked past the plunger of the syringe, dripping over the compounders gloves, chemotherapy mat and hood and gown.In the second instance the same thing happened with the syringe with liquid leaking out past the plunger and getting on the compounder's gloves and the work surface.We have pulled the syringes from that lot as we do not want to use to compound hazardous drugs.

Manufacturer Narrative

H.6.Investigation summary: fifty-two (52) samples were received from the customer for investigation in unopened blister packs.Thirteen (13) of the returned samples were selected at random and were leak tested with none of the samples leaking.A device history record (dhr) review was performed on batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Possible root cause, 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.Corrective and preventative action (capa: 55639) was opened to investigate.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.H3 other text : see section h.10.

Event Description

It was reported that the syringe 60ml ll tip 1ml 2 oz in 1/4 oz experienced leakage past the stopper/plunger during use.The following information was provided by the initial reporter: material no: 309653 batch no: 9029571.Description: we were compounded chemotherapy twice this week and had leakage using bd 60 ml luer lock syringes.In the first instance, (b)(6) the medication we were using leaked past the plunger of the syringe, dripping over the compounders gloves, chemotherapy mat and hood and gown.In the second instance the same thing happened with the syringe with liquid leaking out past the plunger and getting on the compounder's gloves and the work surface.We have pulled the syringes from that lot as we do not want to use to compound hazardous drugs.

• Brand Name: SYRINGE 60ML LL TIP 1ML 2 OZ IN 1/4 OZ
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8995143
• MDR Text Key: 160315476
• Report Number: 1911916-2019-00944
• 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: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 309653
• Device Lot Number: 9029571
• Date Manufacturer Received: 08/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other