MAUDE Adverse Event Report: COVIDIEN DOVER; CATHETER, RETENTION TYPE, BALLOON

Model Number 6146LL

Device Problem Material Separation (1562)

Patient Problem Not Applicable (3189)

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a urine drain bag.The customer reports the tip broke off when it was being put into the foley port.No harm to patient.

Manufacturer Narrative

The sample received was sent to our supplier for evaluation.One picture was sent for investigation.After performing a visual inspection per product specification, the broken syringe tip was observed.The device history record (dhr) file was reviewed indicating that product was released meeting all quality standard requirements.The syringe is a component that is purchased through an approved supplier.The following investigation results were provided by the supplier.A potential root causes for the syringe tip breaking off could be due to the assembly process at or the user using too much force on the syringe causing the tip to break off.The assembly process was investigated to determine if this was the root cause for damage to the syringe tip.As syringes are making their way through the machine, the machine automatically separates defective syringes.If the syringe was misplaced into the machine, it would have caused greater damage to the syringe than what was reported.Therefore, it is unlikely that the assembly process is the root cause of the broken syringe tip.Another potential root cause was due to user error.It is possible that the user was using too much force when they had inserted an object onto the syringe tip.The syringe was completely intact and not leaking prior to user use.Therefore, it is likely that the cause of the broken syringe tip was due to the user using too much force.No corrective action was necessary due the root cause that was determined to be subjective by the user.It is likely that the customer used too much force when inserting the object onto the syringe tip.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DOVER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 20101 ; MX 20101
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana 20101 ; MX 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6335570
• MDR Text Key: 67596153
• Report Number: 9612030-2017-05004
• Device Sequence Number: 1
• Product Code: EZL
• 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,Followup
• Report Date: 11/20/2017

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: Health Professional
• Device Model Number: 6146LL
• Device Catalogue Number: 6146LL
• Device Lot Number: 608953364X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: 01/26/2017
• Supplement Dates FDA Received: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1