MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE REGULAR LUER RP; SYRINGE, PISTON

Model Number 8881560224

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway, the results will be shared upon completion.

Event Description

The customer reported that the tips of the syringes were bent.The issue was discovered prior to use.

Manufacturer Narrative

H 3 evaluation summary a device history record (dhr) review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received two unpackaged samples.A complete investigation was performed.Both samples were received in the cap and sleeve with the heat stake broken on both.Visual inspection to the quality inspection standard (qis) was conducted.Improper assembly of the rubber tip onto the plunger rod was identified on one of the syringe samples.A bent luer tip was identified on the second syringe sample.One sample with this reported issue would not lead to a rejection of the lot.Based on the inspection of the sample with the plunger issue, the following potential root causes have been identified: during assembly, the plunger rubber tip could have become slightly wedged in its respective work holder and became damaged during the shuttle transfer that occurs during indexing of the rotary assembly machine (ram).Or a rubber tip with a slight malformation may have been received as the raw material.If the malformation was very slight, it could potentially feed into the assembly machine and fully seat onto the plunger.If the rubber tip was fully seated onto the plunger, the high plunger sensor on the ram would not have detected this issue.Based on the inspection of the sample with the bent tip the most likely root cause has been identified: during inspection of the sample it was noted that there was a white stress mark at the base of the luer which indicates the syringe most likely got caught on the conveyor during manufacturing.Control mechanisms are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all qis during the syringe assembly processes.The manufacturing site maintains a material verification processes.The manufacture of all molded, printed, assembled, and packaged product is conducted within a validated process, inside a controlled manufacturing area.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications, and molded components are visually and physically tested for adherence to the qis.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, and product evaluation and documentation requirements.Periodic audits are conducted to ensure the quantity of barrel inner dimension silicone lubricant is within specification limits.Process inspectors are required to conduct visual and physical evaluations of the product and packaging, to the qis, at prescribed intervals during the manufacture of all lots and shop orders, and cannot release product unless the required acceptable quality levels (aql) has been met per the specification.A lot cannot be released unless it passes specification requirements.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.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE REGULAR LUER RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10049340
• MDR Text Key: 190698710
• Report Number: 1915484-2020-01166
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521012261
• UDI-Public: 20884521012261
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

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
• Device Operator: No Information
• Device Model Number: 8881560224
• Device Catalogue Number: 8881560224
• Device Lot Number: 934360X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 05/12/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 06/29/2020
• Patient Sequence Number: 1