MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. UNKNOWN PERITONEAL CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number UNKNOWN PERITONEAL CATHETER

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Title comparison of early mechanical and infective complications in first time blind, bedside, midline percutaneous tenckhoff catheter insertion with ultra-short break-in period in diabetics and non-diabetics: setting new standards source peritoneal dialysis international, volume 36, 2016 (655¿661) article number: 6 date of publication: 4 february 2016.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed from january 2009 to december 2013, the authors report their findings on the complications of short break in period for pd catheter insertion in 256 diabetic and non diabetic patients.As reported, early complications occurring within 4 weeks of pd catheter insertion are poor catheter outflow in diabetics and 16 non diabetics, catheter migration was also significantly higher in the non diabetic group (11) vs (2) in the non diabetic, catheter reinsertion/repositioning was significantly lower in the diabetic group (5 vs 16),.It was also stated that other complications include omental wrap (5), catheter luminal clot (1), intra-abdominal adhesions (2), cause unidentified (2), dialysate leak (16), visceral injury/mesenteric tear (1), bleeding/exit-site bleeding (1), rectus sheath hematoma(1), early peritonitis(3), overall early mechanical complications (40), primary catheter non function (24).

• Brand Name: UNKNOWN PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8097143
• MDR Text Key: 128287965
• Report Number: 3009211636-2018-00363
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2018

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: UNKNOWN PERITONEAL CATHETER
• Device Catalogue Number: UNKNOWN PERITONEAL CATHETER
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1