MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL; PISTON SYRINGE

Model Number	305064
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9155510.Medical device expiration date: 2024-05-31.Device manufacture date: 2019-06-04.Medical device lot #: 9269901.Medical device expiration date: 2024-08-31.Device manufacture date: 2019-09-26.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that medication leaked past the syr 10ml ll w/ndl 18x1-1/2 blunt fill plunger during use.Lot# 9269901 was reported to have had 118 occurrences of the event, while lot# 9155510 had an unspecified number of occurrences.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "recently, we have had numerous instances of drug fluid leaking from the syringe into the space between the first and second ribs of the plunger.".
Additional Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, 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.
Event or Problem Description
It was reported that medication leaked past the syr 10ml ll w/ndl 18x1-1/2 blunt fill plunger during use.Lot# 9269901 was reported to have had 118 occurrences of the event, while lot# 9155510 had an unspecified number of occurrences.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "recently, we have had numerous instances of drug fluid leaking from the syringe into the space between the first and second ribs of the plunger.".

• Brand Name: SYR 10ML LL W/NDL 18X1-1/2 BLUNT FILL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9396640
• Report Number: 2243072-2019-02690
• Device Sequence Number: 2642135
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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
• Operator of Device: Other
• Device Model Number: 305064
• Device Catalogue Number: 305064
• Device Lot Number: SEE SECTION H.10.
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other