MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SYRINGE 5ML LL TIP BULK CONVENIENCE PAK; PISTON SYRINGE

Model Number 309703

Device Problem Leak/Splash (1354)

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

Event Date 11/13/2019

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.

Event Description

It was reported that leakage occurred before use with a syringe 5ml ll tip bulk convenience pak.The following information was provided by the initial reporter, "it was reported that the syringes are leaking from the plunger.They have several scar's in place right now regarding leaking syringes.They have identified a couple more lots of the bd syringes that are leaking from the plunger.The customer would like to schedule a phone call so they can discuss a plan as well as this issue.They really would like this taken care of because they don't want it to impact their product more than it already has.Scar details: 517 leaking syringes found during visual inspection of finished product.Syringes leaking from under the safety seal." 517 occurrences.

Event Description

It was reported that leakage occurred before use with a syringe 5ml ll tip bulk convenience pak.The following information was provided by the initial reporter, "it was reported that the syringes are leaking from the plunger.They have several scar's in place right now regarding leaking syringes.They have identified a couple more lots of the bd syringes that are leaking from the plunger.The customer would like to schedule a phone call so they can discuss a plan as well as this issue.They really would like this taken care of because they don't want it to impact their product more than it already has.Scar details: 517 leaking syringes found during visual inspection of finished product.Syringes leaking from under the safety seal." 517 occurrences.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was performed for final lot number 9091753 and the sub-assembly product lot numbers 9042839 and 9044873.During the production process of sub-assembly lot number 9042839, there were no quality issues detected and all inspections were within specification.During the production process of sub-assembly lot number 9044873, a quality notification was raised for the issue of foreign matter.In response to the quality notification, all affected product was held for inspection before release.During the final packaging process, no quality issues were detected for final lot number 9091753.To further investigate this incident, both physical samples and picture samples were provided for evaluation by our quality engineer team.Through examination of the picture samples, leakage was observed past the second rib of the stopper component.Three ziploc bags containing six used syringes belonging to final lot number 9091753 were received and all of the samples exhibited signs of leakage past stopper.A number of the syringes appeared to have damage to the flange area.No foreign matter was observed within the fluid pathway of the used syringes.Two sealed convenience trays belonging to final lot number 9091753 were also received for evaluation.Within the first tray, ten syringes were found to have flange damage with signs of plastic foreign matter behind the stopper.Within the second tray, four syringes were found to have flange damage with signs of plastic foreign matter behind the stopper.This foreign matter was likely a result of the flange damage.All of the unused samples were functionally tested and no signs of leakage were observed.Though it could not be observed within the returned used samples, it is possible that the plastic foreign matter from the flange damage became placed between the stopper and the syringe barrel wall, allowing a channel for leakage in a small amount of syringes.A corrective action plan and preventive action plan has been opened for this incident to further investigate the damage to the syringe and the potential impacts of the resulting foreign matter on leakage.

• Brand Name: SYRINGE 5ML LL TIP BULK CONVENIENCE PAK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9525722
• MDR Text Key: 190484084
• Report Number: 9610847-2019-00771
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097037
• UDI-Public: 30382903097037
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: 309703
• Device Catalogue Number: 309703
• Device Lot Number: 9091753
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other