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

Model Number	1186000777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2021
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 tips of the syringe broke off when attaching them to pga pumps.There was no patient harm reported.
Additional Manufacturer Narrative
See section d4 for the lot number provided, as the sample has been received by the customer.See section d8/d9 for the date the device was returned to the manufacturer.(b)(4).
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device history record for the lot control and the shop order indicates that product and specification requirements were met with no non-conforming product identified relating to this reported issue.The manufacturing site has received one sealed representative sample for the evaluation.A complete investigation was performed.Upon visual evaluation, no issue was observed.Leak test was conducted to verify the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.The syringe passed all leak testing performed.As a result of the current investigation including product analysis of the physical representative sample provided, no issues have been confirmed.At this time, a corrective and preventive action is not deemed necessary.A quality alert will be distributed to necessary quality and production personnel to heighten awareness of the reported condition.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 60ML SYRINGE LUER LOCK TIP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11783311
• Report Number: 1282497-2021-10154
• Device Sequence Number: 14430558
• Product Code: FMF
• UDI-Device Identifier: 10884521189645
• UDI-Public: 10884521189645
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2021

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: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 103405X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021; 04/30/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/08/2021; 08/17/2021
• Patient Sequence Number: 1