MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 SURGICAL CLIPPER BLADE (FOR GENERAL USE)

Model Number	4461A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Material no.: 4461a, batch no.: 0004177456.It was reported that debris was found inside trays.Verbatim: (b)(6), ''not enough information provided'' hello please see the pic below.This item was sent from our local warehouse (b)(6).As becton dickinson is the manufacturer i felt that it was important enough to share with you that these came in unsterile.Debris has been found in these trays lot # 0004177456.
Additional Manufacturer Narrative
(b)(4).Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no.: 4461a.Batch no.: 0004177456.It was reported that debris was found inside trays.Verbatim: srg, not enough information provided.Hello please see the pic below.This item was sent from our local warehouse azdc in chandler, arizona.As becton dickinson is the manufacturer i felt that it was important enough to share with you that these came in unsterile.Debris has been found in these trays lot # 0004177456.
Additional Manufacturer Narrative
Based on the photo sent by your facility, it was determined that personnel may be related to the reported defect if the instructions for use are not followed properly.This may be related to personnel due to debris falling onto the tray as observed in the tray through photographs.Master production records were reviewed for the lot number and no non-conformances were noted during the manufacturing of this lot.Our records indicate that the reviewed batch record passed all the in-process inspection.This event will be track and trended h3 other text : see narrative.

• Brand Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Common Device Name: SURGICAL CLIPPER BLADE (FOR GENERAL USE)
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13180107
• Report Number: 3004932373-2021-00549
• Device Sequence Number: 5710465
• Product Code: OJU
• UDI-Device Identifier: 10885403142192
• UDI-Public: (01)10885403142192
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: 4461A
• Device Catalogue Number: 4461A
• Device Lot Number: 0004177456
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown