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)(6) 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: two photos were received by our quality team for investigation.Through visual inspection, no anomalies were observed; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001394825 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
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: 14320813
• Report Number: 9680904-2022-00020
• Device Sequence Number: 5198265
• 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): 06/13/2022

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 Expiration Date: 10/31/2025
• Device Model Number: 4540A
• Device Catalogue Number: 4540A
• Device Lot Number: 0001394825
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/13/2022
• 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