MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number SN-663

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Convulsion, Tonic (2223); Unintended Radiation Exposure (4565)

Event Date 11/04/2021

Event Type  Injury  

Event Description

According to the reporter, when suturing the wound after central venous line insertion, the needle held by the needle holder detached from the thread. an x-ray was taken and the needle was located in the soft tissues, a further incision was made to retrieve the needle.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOSOF
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12844595
• MDR Text Key: 281019470
• Report Number: 9612501-2021-01920
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521079724
• UDI-Public: 10884521079724
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: SN-663
• Device Catalogue Number: SN-663
• Device Lot Number: D1E0887FY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/19/2021
• Date Device Manufactured: 05/14/2021
• 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