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

Model Number 4540A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2022

Event Type  Injury  

Event 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.

Manufacturer Narrative

(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

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 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
• Type of Device: 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
• MDR Text Key: 293185948
• Report Number: 9680904-2022-00021
• Device Sequence Number: 1
• Product Code: HEE
• UDI-Device Identifier: 10885403143243
• UDI-Public: (01)10885403143243
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 4540A
• Device Catalogue Number: 4540A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other