MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PARAPAC PLUS; PNEUPAC PARAPAC PLUS; PNEUPAC PARAPAC PLUS DISPOSA

Catalog Number 510A2338

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2020

Event Type  malfunction  

Event Description

It was reported that the patent valve was missing on receipt of goods.No patient injury was reported.

Manufacturer Narrative

Manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No product sample was received.No testing or visual inspection could be performed, as no product was made available for evaluation.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: PARAPAC PLUS
• Type of Device: PNEUPAC PARAPAC PLUS; PNEUPAC PARAPAC PLUS DISPOSA
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; bramingham business park, enterprise way; luton, bedforshire LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15401448
• MDR Text Key: 305880052
• Report Number: 3012307300-2022-18628
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 510A2338
• Device Lot Number: 3944643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2022
• 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
• Patient Sequence Number: 1