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

Model Number	8881535770
Medical Device Problem Codes	Break (1069); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
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.
Event or Problem Description
The customer reported that the syringes have broken tips.
Additional Manufacturer Narrative
Additional information: h4: the reported lot number was manufactured and packaged on november 24-25, 2020.H6 investigation findings: 4247 appropriate term/code not available -- device print problem.Investigation summary.Thirteen samples from lot 029414x were received for evaluation.Nine of the syringe samples received were in sealed packages and four of the syringe samples were in unsealed packages.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.Broken off catheter tips and multiple cracks on the syringe barrel face and down the barrel shoulder into the barrel wall was identified on all thirteen syringe samples.Visual inspection of the sealed package syringe samples also identified missing numeral ¿35¿, missing one graduation line, and missing ¿ml¿ on one of the syringe samples and partially missing ¿ml¿ on two of the syringe samples.Visual inspection of the unsealed package syringe samples identified partially missing ¿ml¿ on three of the syringe samples.The device history record (dhr) for lot 029414x was reviewed.During the manufacturing of the syringe assemblies, syringes were visually and physically inspected with no issues recorded relating to the reported issue.The molded syringe barrel inspection reports were reviewed with no issues recorded relating to this customer report.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.Based on the available information, an exact root cause could not be determined.Per the manufacturing site¿s procedure, complaint trends are evaluated during the monthly corrective and preventive action (capa) meeting to determine if a capa is warranted.A manufacturing trend does not exist for the same or similar reported condition.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel for awareness.

• Brand Name: 35ML SYRINGE CATHETER TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11329922
• Report Number: 1915484-2021-01212
• Device Sequence Number: 1112463
• Product Code: FMF
• UDI-Device Identifier: 20884521012209
• UDI-Public: 20884521012209
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 8881535770
• Device Catalogue Number: 8881535770
• Device Lot Number: 029414X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1