MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS ADAPTER

Model Number UNKNOWN DYALISIS

Device Problems Hole In Material (1293); Fitting Problem (2183); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(4) 2015 that a customer had an issue with an adapter.The customer states that the home patient went in to have her transfer set replaced because there was a hole in the catheter.The rn attempted to install the transfer set but noticed that it was not fitting well to the adapter.Upon connection, it did not look secure.The transfer set then fell off about a week later, (b)(6) 2015.The patient had been using peritoneal dialysis (pd) for about two years and was performing automated peritoneal dialysis (apd).There was no instrumentation or device used in an attempt to make the connection.Alcavis was used to sterilize the connection.There was no damage or residue on the threads of the connector noticed.The covidien adaptors looked perfectly normal.The rn was not aware of anything that may have caused the difficulty with the connection.The patient was the operator of the device.There was no patient injury, medical intervention, or adverse reaction reported with this event.The patient was given antibiotics as a precaution.There was a culture done, but the results were not known at the time of conversation.

Manufacturer Narrative

Submit date: 04/22/2015.An investigation is currently underway; upon completion, the results will be forwarded.

Manufacturer Narrative

The manufacturing lot number associated with this complaint was not provided.Without the lot number, a device history record (dhr) review could not be performed.All dhr's are reviewed for accuracy prior to product release.The complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause of this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.The instructions for use (ifu) indicates that infection is a potential complication inherent to these medical procedures and does not have association with the devices function.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.As per procedure, incoming performs acceptance sampling inspection, which would identify issues in the adapter ports.This complaint will be used for tracking and trending purposes.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: DIALYSIS ADAPTER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4717630
• MDR Text Key: 5738236
• Report Number: 3009211636-2015-00212
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN DYALISIS
• Device Catalogue Number: UNK DYALIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR