MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; KIT, REPAIR, CATHETER, HEMODIALYSIS

Model Number	8888541123
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on (b)(6), during hemodialysis the device¿s arterial luer adapter became detached from the(bionic) extension lines.The luer adapter had to be reconnected on the arterial line.It was suspected that the patient was disconnecting the arterial lines.No patient injury.
Additional Manufacturer Narrative
The product 8888541123, hemodialysis catheter repair kit, was utilized to repair the catheter associated with the event reported under report number 3009211636-2017-05330.There was no product failure associated with the item 8888541123 and therefore there will be no additional supplemental reports submitted for this item.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, on (b)(6) 2017, during hemodialysis the device¿s arterial luer adapter became detached from the(bionic) extension lines.The luer adapter had to be reconnected on the arterial line.It was suspected that the patient was disconnecting the arterial lines.No patient injury.

• Brand Name: PALINDROME
• Common Device Name: KIT, REPAIR, CATHETER, HEMODIALYSIS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 6968357
• Report Number: 3009211636-2017-05331
• Device Sequence Number: 11065547
• Product Code: NFK
• UDI-Device Identifier: 10884521135543
• UDI-Public: 10884521135543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2019
• Device Model Number: 8888541123
• Device Catalogue Number: 8888541123
• Device Lot Number: 1428800041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 52