MAUDE Adverse Event Report: COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON

Model Number	8881501160
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the syringes were received with no suction.Additional information provided by the customer stated that the issue seems to be that the plungers did not fit the barrels correctly, causing loss of suction.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received four hundred-seventy packaged samples with this customer report.A complete investigation was performed.Visual inspection to the quality inspection standard (qis) was conducted.No issues were identified.Leak testing was performed on a statistical sample size from the syringe samples received.The leak test is conducted to verify the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.All of the syringe samples tested passed the leak testing.The manufacturing lab performed plunger activation force testing on a statistical sample size of pieces.The result for the plunger movement force showed the maximum does fail the specification limit.Stylet testing was performed on the needle assemblies removed for plunger movement testing.The stylet testing is done to check for obstruction of the lumen to assure adequate flow rates of the finished product.One of the hooded needle assemblies failed the stylet testing, and this most likely explains the failure of the plunger movement force testing.The hooded needle assembly was reattached to the syringe assembly and leak tested.The syringe drew water, but there were air bubbles, indicating a partially occluded needle.Possible root causes for a syringe not being able to draw up liquid could be a clogged or partially clogged cannula.This may be the most likely root cause based on the sample evaluation performed on the returned samples.Another possible cause could be uneven distribution of silicone.This would make it difficult to move the plunger.Also, improper technique when using the syringe is another possible cause.Process controls already in place are, a high plunger detect on the assembly machine which would detect severely occluded cannulas.The plunger is exercised during the assembly process to redistribute the silicone in the barrel and on the rubber tip.These syringes are designed to be a single use syringe.Leak testing is conducted to ensure the syringe draws, holds, and expels fluid properly.The hooded needle assemblies are not manufactured at this manufacturing site, however, inspectors routinely examine product to ensure it meets acceptable quality levels.A lot cannot be released unless it passes visual and physical testing requirements.The criteria have not been met for a formal investigation at this time.Complaint trends will be evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML TB SYR 25G X 5/8 DETACH RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11276942
• Report Number: 1915484-2021-01209
• Device Sequence Number: 19511233
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: No Information
• Device Model Number: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 020251X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1