MAUDE Adverse Event Report: WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB NAVINA CONSUMABLE SET REGULAR; GASTROINTESTINAL TUBES AND ACESSORIES

Model Number	69003
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	12/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This concerns a device from a manufactured lot, which has not been distributed to usa, but only distributed in europe.For this reason, the field safety corrective action and recall taken for this device and lot does not involve usa.The used rectal catheter regular involved in the event, (supplied within the consumable set regular) was not returned for investigation.Therefore, the manufacturer is precluded from establishing conclusions of the root cause behind this particular event.No further information is expected.It is however speculated the event could have been caused by a possible deficiency in the catheter's balloon material, since this had been identified for a few other catheters of the same lot, distributed to sites in europe.The lot with potential deficient catheters was subject to a recall, issued in europe in december 2018.The catheter involved in the event had been distributed before the manufacturer was aware of the quality issue and before issuing a recall notice to those countries where distributed.A root cause analysis and long term corrective and preventive action was implemented with immediate effect.
Event or Problem Description
A patient with previous medical history of a bowel perforation incident, when using another manufacturer's product for trans anal irrigation, reported pain and suspected balloon burst and damage to intestine when using the rectal catheter regular (supplied within the consumable set regular).The patient sought hospital care the day after.The health care provider did not consider it likely caused by the balloon burst.The patient had a contrast scan, but no physical damage was seen.The reporter stated the general diagnosis from the hospital and gps along with the bowel nurse, is that the inner wall of the intestine had been hurt.It was described by reporter as "not a full perforation and hard to see on the scans, but still a trauma".The patient informed she has been to the doctor's regularly since the event, and experience continued abdominal pain and discomfort, and had not healed at time of raising complaint.Treated with analgesic medication for pain and inflammation.Is not using the irrigation system since the event occurred.

• Brand Name: NAVINA CONSUMABLE SET REGULAR
• Common Device Name: GASTROINTESTINAL TUBES AND ACESSORIES
• Manufacturer (Section D): WELLSPECT HEALTHCARE, A DIVISION OF DENTSPLY IH AB; aminogatan 1; p.o. box 14; moelndal, sweden SE-43 121; SW SE-43121
• MDR Report Key: 8266889
• Report Number: 3009632672-2019-00001
• Device Sequence Number: 2287660
• Product Code: KNT
• UDI-Device Identifier: 07392532198403
• UDI-Public: 07392532198403
• Combination Product (Y/N): N
• PMA/510(K) Number: K170487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: 69003
• Device Catalogue Number: 6900340
• Device Lot Number: 427128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 29 YR