MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. OPTIFIX OPEN 20 COUNT; STAPLE, IMPLANTABLE

Catalog Number 0113320

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

The subject product was discarded and not returned for evaluation.As reported, the physician's assistant placed their finger directly over the area where the fastener was deployed.The ifu for the optifix open fixation device precautions: counter pressure should be applied on the target area.Avoid placing hand/finger directly over the area where fastener is being deployed to prevent injury.Based on the information provided, the user did not follow the recommended instructions which caused the reported problem.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Not returned.

Event Description

It was reported by the bd sales rep.That during an open umbilical hernia repair, the surgeon was using the optifix open fixation device for the first time.The sales rep.Advised the surgeon to use adequate counter pressure.The surgeon's physician's assistant applied counter pressure on top on the fascia and under the skin and subq fat.At the first fire, the physician's assistant was hit in the finger and through her glove with the guide wire.The case was finished and the physician's assistant had her blood drawn.

• Brand Name: OPTIFIX OPEN 20 COUNT
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 8798237
• MDR Text Key: 151297369
• Report Number: 1213643-2019-06166
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00801741128950
• UDI-Public: (01)00801741128950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 0113320
• Device Lot Number: HUCS0218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention