MAUDE Adverse Event Report: COVIDIEN 3ML SYRINGE PURPLE EN-FIT TIP; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8881103015

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

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 the rn was able to draw medication into the syringe but was unable to administer medication since the plunger was stuck on the syringe and was unable to push in or pull back on plunger.

• Brand Name: 3ML SYRINGE PURPLE EN-FIT TIP
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9396186
• MDR Text Key: 177374027
• Report Number: 1017768-2019-00743
• Device Sequence Number: 1
• Product Code: PNR
• UDI-Device Identifier: 10884521545403
• UDI-Public: 10884521545403
• 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: Other
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881103015
• Device Catalogue Number: 8881103015
• Device Lot Number: S14498
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1