MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881520657
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
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 when they were mixing the drugs a small piece of plastic was noticed inside of the syringe.There was no patient harm reported.
Additional Manufacturer Narrative
H3 evaluation summary: the device history record (dhr) cannot be reviewed because the lot number is unknown.The manufacturing site received one syringe sample in an opened package.A complete investigation was performed.Visual inspection to the quality inspection standard (qis) was conducted.A large plastic string was identified on the inside diameter of the syringe barrel.The plastic string was loose inside the syringe barrel and was visible on the face and side of the rubber tip and extended between two of the ribs of the plunger rod.The most probable root cause for the plastic string is determined to have been introduced into the syringe during the assembly process.There is a potential for plastic strings to originate during the transport of the molded components, including the syringe plunger, from the molding machines to the assembly process.Blow over tubes are cleaned and inspected at prescribed intervals.Visual inspections are performed throughout the length of each production run and in the event issues such as particulate are identified, corrective actions are performed to eliminate the source.Per procedure, complaint trends are 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.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel through a quality alert.

• Brand Name: 20ML SYR LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11003859
• Report Number: 1915484-2020-01199
• Device Sequence Number: 14339802
• Product Code: FMF
• UDI-Device Identifier: 20884521012155
• UDI-Public: 20884521012155
• Combination Product (Y/N): N
• 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): 03/08/2021

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: 8881520657
• Device Catalogue Number: 8881520657
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1