MAUDE Adverse Event Report: REDAX SPA ROUND JACKSON PRATT CH 15; ROUND DRAIN "JACKSON PRATT" TYPE

Model Number 24220

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Necrosis (1971); Sepsis (2067); Fasciitis (2375)

Event Date 01/12/2018

Event Type  malfunction  

Manufacturer Narrative

Redax was not able to perform a complete investigation since the lot number nor the sample were available.We have tried to require to our (b)(4) distributor the lots sold to the hospital but they were not able to identify them as the sale is not performed directly to the hospital but to (b)(6) supply chain.For these reasons, the analysis has been done just on the basis of the information provided by the hospital.The chronology-timeline events described are quite confused, even if well detailed.It appears that the drain was handled not correctly and several times as it was positioned in the right side then they found it in the abdo.It appears from the description that the drain went completely inside the patient and it was tugged and moved in order to re-position it.All these operations could have weakened or damaged the drain, causing consequently the rupture.No similar cases have been registered from last year till today.The raw material has not been changed and it is in compliance with the tests required by international standard iso 10993-1.No actions will be done for the moment, just take under control the situation and the market.

Event Description

Elective laparoscopic ovarian cystectomy, converted to laparatomy on (b)(6) 2018.Drain inserted through right lateral port site at end of procedure to allow drainage of free fluid in the abdominal cavity.Sutured in place.Drain migrated into abdominal cavity overnight (confirmed on axr).Patient taken for laparoscopic removal of drain (b)(6) 2018 (unable to retrieve from abdominal wall under uss guidance in theatre).Straight forward procedure and drain apparently removed.Patient required ct abdo/pelvis overnight (b)(6) 2018 due to sepsis, necrotizing fasciitis on anterior abdo wall, also showed drain in-situ from liver to pelvis.Returned to theatre (b)(6) 2018.Fragment of drain around 20 cm retrieved from right side of abdomen.End jagged - unclear how drain fractured.Laparatomy wound explored in theatre with consultant surgeon - around 100 ml of pus expelled tissue healthy with no evidence of necrotizing fasciitis.Thorough washout and vacuum system inserted.Wound left open with plan to return to theatre for eua, removal of vacuum system and probable closure 24-48 h later.

• Brand Name: ROUND JACKSON PRATT CH 15
• Type of Device: ROUND DRAIN "JACKSON PRATT" TYPE
• Manufacturer (Section D): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer (Section G): REDAX SPA; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• Manufacturer Contact: daniela malavasi ; via galileo galilei 18; poggio rusco, mantova 46025 ; IT 46025
• MDR Report Key: 7734468
• MDR Text Key: 115776324
• Report Number: 3013058659-2018-00004
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24220
• Device Catalogue Number: 24220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 29 YR