MAUDE Adverse Event Report: COVIDIEN 10ML ORAL MED SYRINGE (CLEAR); CONTAINER, LIQUID MEDICATION, GRADUATED

Model Number 8881907102

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2019

Event Type  malfunction  

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 Description

The customer reported that upon opening the of cartons of the syringes, there were broken pieces of syringes inside the packaging.Additional information received from the customer stated that the tip of the syringes was broken and some of them were snapped off clearly.Also, few of the syringes had cracked barrels.No patient involved.

Manufacturer Narrative

A review of the device history record was performed for the reported lot number.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Few pictures have been received for the evaluation.Upon visual evaluation of the picture, the reported condition is confirmed.The method of root cause analysis that was implemented in this investigation was to conduct a six m assessment.The assembly system was reviewed, the damage observed is due to misalignment of sensors and jams in the rotary assembly machine (ram).Based on the information available, and the investigation findings, a new formal investigation is not deemed necessary at this time.Controls are in place to prevent the observed issue and no new or unanticipated issue was observed.

• Brand Name: 10ML ORAL MED SYRINGE (CLEAR)
• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9252965
• MDR Text Key: 172702534
• Report Number: 1424643-2019-00549
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 10884521014640
• UDI-Public: 10884521014640
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881907102
• Device Catalogue Number: 8881907102
• Device Lot Number: 18J13863X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/14/2019
• Patient Sequence Number: 1