MAUDE Adverse Event Report: AESCULAP AG TC MAYO-HEGAR NDL HOLDERHVYSERR205MM; DUROGRIP NEEDLEHOLDERS

Model Number BM067R

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.Medwatch report # 450015000-2021-8015.

Event Description

It was reported that there was an issue with bm067r - tc mayo-hegar ndl holderhvyserr205mm.According to the complaint description, during cesarean section procedure part of a needle driver insert fell into a patient.An additional medical intervention was necessary.The adverse event is filed under (b)(4) reference (b)(4).

Event Description

Clarification was received: there was no delay caused by the breakage in the original surgery.However, postoperatively, the patient underwent another procedure (not specified), as well as attending multiple physician appointments, and required the performance of additional x-rays.

Manufacturer Narrative

B5 - description updated.H6 - updated codes.

Event Description

No updates.

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: TC MAYO-HEGAR NDL HOLDERHVYSERR205MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12739301
• MDR Text Key: 279625116
• Report Number: 2916714-2021-00213
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653028276
• UDI-Public: 4038653028276
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2021,12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM067R
• Device Catalogue Number: BM067R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2021
• Distributor Facility Aware Date: 10/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 176 KG
• Patient Race: Black Or African American