MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LUER-LOK GAMMA IRRADIATED; PISTON SYRINGE

Catalog Number	304406
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 10ml luer-lok gamma irradiated had a crack and leaked.The following information was provided by the initial reporter: material no.: 304406, batch no.: 8324556.It was reported that there is a crack around the bottom of the luer lock hub and there was leakage back into the plunger portion of the syringe.Per supplier notification customer report "leakage was at the hub" was not confirmed.Returned coset syringe was connected to flow-through housing and swan-ganz catheter model 151f7 from lab for priming.No leakage was detected from the syringe during priming.However cracks was found around the bottom of the luer lock.The cracks did not extend to the barrel or male luer of the syringe thus did not cause any leakage.Customer report of "leaking back into the plunger portion of the syringe" was also not confirmed.Coset system was primed and went through multiple cycles of aspiration and injection at rate 10cc in 4 seconds (as recommended by vigilance user manual).No leakage was detected from the coset system during the cycles of aspiration and injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-02-08.H6: investigation summary.A physical sample and two photos displaying the luer potion of a loose syringe were received and evaluated.It was observed in the sample provided, there was a 10ml syringe inside an unknown injection device with an infusion device attached.The physical syringe inside appeared to be consistent with the photo provided.It was observed in the photo that there was a crack around the base of the luer.Based on the verbatim, testing was performed, and no leakage was observed.Therefore, the leakage defect was not confirmed.Potential root cause for the cracked luer defect could not be confirmed based on the evidence provided.The syringe was used in an unknown assembly process after leaving the manufacturing site.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 syringe 10ml luer-lok gamma irradiated had a crack and leaked.The following information was provided by the initial reporter: material no.: 304406, batch no.: 8324556.It was reported that there is a crack around the bottom of the luer lock hub and there was leakage back into the plunger portion of the syringe.Per supplier notification.Customer report "leakage was at the hub" was not confirmed.Returned coset syringe was connected to flow-through housing and swan-ganz catheter model 151f7 from lab for priming.No leakage was detected from the syringe during priming.However cracks was found around the bottom of the luer lock.The cracks did not extend to the barrel or male luer of the syringe thus did not cause any leakage.Customer report of "leaking back into the plunger portion of the syringe" was also not confirmed.Coset system was primed and went through multiple cycles of aspiration and injection at rate 10cc in 4 seconds (as recommended by vigilance user manual).No leakage was detected from the coset system during the cycles of aspiration and injection.

• Brand Name: SYRINGE 10ML LUER-LOK GAMMA IRRADIATED
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11317300
• Report Number: 1213809-2021-00076
• Device Sequence Number: 2737205
• Product Code: FMF
• UDI-Device Identifier: 00382903044061
• UDI-Public: 00382903044061
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 304406
• Device Lot Number: 8324556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1