MAUDE Adverse Event Report: CAREFUSION, INC GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8IN; SPECULUM, VAGINAL, METAL

Model Number	GL11
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
5787062 bd has determined that a portion of the products were packaged and marked incorrectly, specifically: catalog number gl11, lot number d22xbb may be marked, packaged, and labeled as catalog number gl31, lot number d22xbb - catalog number gl31, lot number d22xbb may be marked, packaged, and labeled as catalog number gl11, lot number d22xbb.Investigation of returned complaint devices led to an investigation by the manufacturer, resulting in confirmation of a partial product mix for each lot.Voluntary recall, v.Mueller¿ graves vaginal speculum and pederson vaginal specula with bd recall number: bdsur# 1423507-02/16/2023-002-c.
Event or Problem Description
Material# gl11 batch# d22xbb verbatim: customer received the wrong item in the correct packaging.They received pedersen speculum inside a graves medium (gl11).Po 24040016336.Bd has determined that a portion of the products were packaged and marked incorrectly, specifically: catalog number gl11, lot number d22xbb may be marked, packaged, and labeled as catalog number gl31, lot number d22xbb - catalog number gl31, lot number d22xbb may be marked, packaged, and labeled as catalog number gl11, lot number d22xbb.Investigation of returned complaint devices led to an investigation by the manufacturer, resulting in confirmation of a partial product mix for each lot.Voluntary recall, v.Mueller¿ graves vaginal speculum and pederson vaginal specula with bd recall number: bdsur# 1423507-02/16/2023-002-c.

• Brand Name: GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8IN
• Common Device Name: SPECULUM, VAGINAL, METAL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16427501
• Report Number: 1423507-2023-00086
• Device Sequence Number: 17467142
• Product Code: HDF
• UDI-Device Identifier: 10885403042744
• UDI-Public: (01)10885403042744
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2023
• Report Date (Section F): 02/23/2023

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: GL11
• Device Catalogue Number: GL11
• Device Lot Number: D22XBB
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/23/2023