MAUDE Adverse Event Report: COVIDIEN UNKNOWN SYRINGE; SYRINGE, PISTON

Model Number 1183500777

Device Problems Break (1069); Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

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.

Event Description

The customer reported that a monoject 35 ml syringe with an unknown product number was being filled by their onsite pharmacy and upon use on the unit, they found the tip has broken off.The customer further stated that this issue is causing the hospital to waste quite a bit of fentanyl.Additional information was received on 28-apr-2020 stating that leaking was noticed as soon as the cap was taken off to start priming.The customer also stated that the pharmacy did not encounter any issue while they were filling the syringe.Issue was only noticed once it was on the unit.

Manufacturer Narrative

Section d4 has been updated to include the model number, catalog number, and udi of the product involved in this incident.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One unpackaged sample was received at the manufacturing site for evaluation.The sample was received with the rubber tip end of a two-piece plunger rod inside the syringe barrel and a fentanyl label was adhered to the outside of the syringe barrel.Upon a visual and functional evaluation of the sample, the reported issue was confirmed; the luer tip was broken off of the syringe barrel near the base of the barrel face.From the returned sample an exact root cause was not able to be determined.Please note: it is known, from the description of the event, that these syringes are being filled with fentanyl and that they are being tip capped in the pharmacy with a special cap that is tamper evident (as confirmed by the customer).It is possible that there is extra force applied to remove the tamper evident tip cap that cah cannot reproduce without knowing the part number of this part to test when applied to our syringes.The following 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 quality inspection standards during the syringe assembly processes.1.The manufacturing site maintains material verification processes.The raw materials must pass an inspection and certification review before release to the floor for production.2.The manufacture of all molded, printed, assembled, and packaged product is conducted within a validated process, inside a controlled manufacturing area.3.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 quality inspection standard.4.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, and product evaluation and documentation requirements.5.Procedures and standard work instructions exist for the set-up, operation and maintenance of the molding machines and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.6.Process inspectors are required to conduct visual and physical evaluations of the product and packaging, to the quality inspection standard, at prescribed intervals during the manufacture of all lots and shop orders and cannot release product unless the required aql has been met per the specification.7.A lot cannot be released unless it passes specification requirements.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UNKNOWN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10017256
• MDR Text Key: 191717077
• Report Number: 1915484-2020-01161
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2020
• Patient Sequence Number: 1