MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC. ADAPTOR TUOHY-BORST; INTERVENTIONAL IMAGING|ACCESSORIES

Model Number ADAPTOR TUOHY-BORST

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information received a smiths medical adaptor tuohy-borst reported during use the adapter put on endoscope had a fluid leak.The cap was manipulated with no resolution.Photos were provided of malfunction.No patient adverse events were reported.

Manufacturer Narrative

Pictures were returned for analysis and revealed that the catheter seal ring was open and not closed.Engineering trials were performed to try, and replicate defect seen in the picture.The seal ring kept rotating the cat to shut the packaging, but it became non-functional.Previous complaints were retrieved and rotated to open and close the knob in order to compare versus the pictures provided.It was observed that when the knob is completely closed, the o-ring is closed and when the knob is open, the seal ring is open.Through the pictures provided it was not possible to analyze why the seal-ring became functional.Three adaptor tuohy-borst samples were returned for analysis.Two samples were labeled as complaint (b)(4) from pn: b1220 per complaint information samples were from lot: 3815699 and one (1) sample was labeled as (b)(4) from pn: b1220 per complaint information sample was from lot: 3834072.The samples were visually inspected, noting that the adaptors were within specification.Water leak testing was then performed with no discrepancies or leaks observed.Relevant documents were reviewed and deemed adequate.The water leak testing procedure was reviewed, finding that samples were found within specifications as returned samples did not exhibited water leakage condition.Based on the evidence, the root cause is unknown as the complaint was not confirmed.

• Brand Name: ADAPTOR TUOHY-BORST
• Type of Device: INTERVENTIONAL IMAGING|ACCESSORIES
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10031098
• MDR Text Key: 190109786
• Report Number: 3012307300-2020-03741
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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: ADAPTOR TUOHY-BORST
• Device Catalogue Number: B1220
• Device Lot Number: 3834072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Manufacturer Received: 04/09/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1