MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881535762
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 plungers were broken.The plastic pieces were inside of the syringe near the black rubber plunger tip.This was discovered when the customer opened the package.

• Brand Name: 35ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9006351
• Report Number: 1915484-2019-01083
• Device Sequence Number: 2837928
• Product Code: FMF
• UDI-Device Identifier: 20884521012193
• UDI-Public: 20884521012193
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 8881535762
• Device Catalogue Number: 8881535762
• Device Lot Number: 914765X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/12/2019
• Patient Sequence Number: 1