MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PNEUPAC PARAPAC PLUS SINGLE LIMB CIRCUIT, PNEUPAC; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Model Number	100/905/340-CH
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, before opening the package, a hair-like substance was found in it; the product was not used.No patient injury was reported.
Additional Manufacturer Narrative
The product was returned for evaluation.Upon visual inspection, a hair-like substance in the unopened package was noted.This is a supplied item and the device history record (dhr) is at the supplier.Manufacture and expiration dates are unknown.The product has been sent to the supplier.Should additional information be returned pertinent to the investigation, a supplemental report will be filed.Operator of device is unknown.No information has been provided to date this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PNEUPAC PARAPAC PLUS SINGLE LIMB CIRCUIT, PNEUPAC
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• 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; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 15397889
• Report Number: 3012307300-2022-18570
• Device Sequence Number: 17758296
• Product Code: BTL
• UDI-Device Identifier: 15019517160215
• UDI-Public: 15019517160215
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2022

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 Model Number: 100/905/340-CH
• Device Catalogue Number: 100/905/340-CH
• Device Lot Number: 190722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 09/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown