MAUDE Adverse Event Report: CONTRACT MEDICAL INTERNATIONAL, GMBH DURA: 8FR 450MM FINISHED GOOD; INTRODUCER SHEATH

Model Number	FG-08045-001
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cmi performed dhr review of the complaint lots (b)(4).There were found no qnrs or deviation in the records.The root cause of the incident is unknown at the time of the initial report.
Event or Problem Description
During the inspection performed by the distributor prior to device distribution, there was found one piece of 8fr durasheath finished good where the inner pouch was not sealed.
Additional Manufacturer Narrative
The problem was detected at the distributor site during the inspection prior to the distribution of the device in the market.The manufacturer performed dhr review of the complaint lot 659821.There were found no non-conformities or abnormalities in the records.Affected sample was not returned for an evaluation as it was discarded by the distributor.From the pictures sent by the distributor it can be seen, there is no sign of sealing on the pouch visible (no deformations, heat maps, etc.).That means no pressure and/or temperature impacted the pouch, so it is evident the packed device could not be inserted into the sealer and had to skip this operation.A material flow in current manufacturing processes was verified.No observation was found.The operators work in accordance with applicable working instructions and line clearance rules.A review of quality system data was done.Neither customer complaint, nor non-conformance was found for this kind of product in last 3 years which is a shelf life of the device.All data signals there is no systemic root cause, most likely this is a single occurrence of the root cause which relates to the organization of the work on the sealing table when the operator inserted non-sealed pouch to completed products.Manufacturing lot 659821 was manufactured prior to the implementation of the sensor for counting of performed seals on the sealers to prevent similar issue.

• Brand Name: DURA: 8FR 450MM FINISHED GOOD
• Common Device Name: INTRODUCER SHEATH
• Manufacturer (Section D): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer (Section G): CONTRACT MEDICAL INTERNATIONAL, GMBH; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• Manufacturer Contact: marketa shanelova ; lauensteiner strasse 37; dresden, 01277 ; GM 01277
• MDR Report Key: 11677710
• Report Number: 3003637635-2021-00003
• Device Sequence Number: 11818433
• Product Code: DYB
• UDI-Device Identifier: 04251244500467
• UDI-Public: 04251244500467
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K181463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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: Other
• Device Expiration Date: 11/15/2021
• Device Model Number: FG-08045-001
• Device Catalogue Number: FG-08045
• Device Lot Number: 659821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown