MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881560125
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
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 to the distributor that there was plastic inside the syringe and when fluid was drawn up it appeared floating.
Additional Manufacturer Narrative
The device history record (dhr)review indicates that there were not any non-conformances detected during the production of the reported lot.One unpacked sample was received with this customer report.A complete investigation was performed.A visual inspection confirmed that a broken piece of plastic material was identified on the inside diameter of the syringe barrel between the rubber tip and the syringe barrel face.The broken plastic piece was not part of the syringe sample received, as the assembled syringe was fully intact, with no visual breakage or cracks.The reported condition of a small piece of broken plastic was in the inner diameter of barrel, in the fluid path has been confirmed.The piece of plastic is large enough that it would not be able to expel from the luer taper.The sample arrived outside of the original packaging and was no longer inside the cap and sleeve, therefore the plant is unable to evaluate how further handing may have impacted the medical device.The exact root cause could not be determined however the manufacturing equipment / process cannot be excluded as well as other post manufacturing handling /shipping of the product.Control mechanisms are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9316427
• Report Number: 1915484-2019-01100
• Device Sequence Number: 2373359
• Product Code: FMF
• UDI-Device Identifier: 20884521012230
• UDI-Public: 20884521012230
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/04/2020

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: 8881560125
• Device Catalogue Number: 8881560125
• Device Lot Number: S-LK907740X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/09/2019
• Supplement Date Received by Manufacturer: 11/09/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 02/04/2020
• Patient Sequence Number: 1