MAUDE Adverse Event Report: COVIDIEN UNKNOWN SYRINGE SYRINGE, PISTON

Model Number 1183500777

Device Problems Break (1069); Fluid 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.

• Brand Name: UNKNOWN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• 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
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: 1183500777
• Device Catalogue Number: 1183500777
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage