MAUDE Adverse Event Report: CAREFUSION, INC PARACERVICAL PUD TRAY CONTROL SYRINGE; SET, ANESTHESIA, PARACERVICAL

Model Number	4540A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that there was a serious patient safety event involving the sponges included in the tray.Verbatim: srg ¿ vh ¿ lot:0001394825 - serious patient safety event involving the sponges.I am the risk manager at medical center, a part of *** healthcare.We had a recent serious patient safety event involving the sponges included in your paracervical/pudendal block tray (cat 4540a).Additionally, another hospital within our system, hospital, had a similar event.We would like to discuss and explore options to not include the 2 sponges in this tray.Please contact me at your earliest convenience to discuss this matters, as it has significant impact on our patient safety practices at (b)(4) healthcare.
Additional Manufacturer Narrative
(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported by the customer that there was a serious patient safety event involving the sponges included in the tray.Verbatim: srg ¿ vh ¿ lot:0001394825 - serious patient safety event involving the sponges.I am the risk manager at medical center, a part of healthcare.We had a recent serious patient safety event involving the sponges included in your paracervical/pudendal block tray (cat 4540a).Additionally, another hospital within our system, hospital, had a similar event.We would like to discuss and explore options to not include the 2 sponges in this tray.Please contact me at your earliest convenience to discuss this matters, as it has significant impact on our patient safety practices at (b)(6) healthcare.

• Brand Name: PARACERVICAL PUD TRAY CONTROL SYRINGE
• Common Device Name: SET, ANESTHESIA, PARACERVICAL
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14321407
• Report Number: 9680904-2022-00021
• Device Sequence Number: 12046434
• Product Code: HEE
• UDI-Device Identifier: 10885403143243
• UDI-Public: (01)10885403143243
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4540A
• Device Catalogue Number: 4540A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown