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

Model Number	8881501160
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
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 are leaking at the base of the hub.There was no harm to the patient or staff.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were not received for the investigation however two photos were provided.In the first photograph, the cap to the plastic sleeve that encases the syringe can be observed.In the photograph, the syringe is indicated to have been manufactured from lot 908444x and is identified as a 1 ml syringe with a 25g x 5/8¿ needle.In the second photograph provided, the top half of a syringe (unknown nominal capacity) with attached needle is shown.The is an arrow that points to where the hub of the needle attaches to the tip of the syringe and is labeled as ¿leaks¿.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without sample, a root cause cannot be determined at this time.If a sample is received at a later date, the complaint will be reopened and the investigation will be updated as needed.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa 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: 8802151
• Report Number: 1915484-2019-01063
• Device Sequence Number: 327592
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 908444X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1