MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® GRIPPER PLUS® SAFETY NEEDLES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-2734-24
Medical Device Problem Codes	Structural Problem (2506); Sharp Edges (4013)
Health Effect - Clinical Codes	Hematoma (1884); Blood Loss (2597)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while a smiths medical gripper needle was in use, it had been bent.Upon removal of the needle, the patient was left with a cut.It was reported to have taken 45 minutes to stop the bleeding as the use of applied pressure and coolpack had no effect.Tranexamic acid was used to end the bleeding.It was also reported that a hematoma had formed.Patient was supplied with pain killers.
Additional Manufacturer Narrative
Additional information: the investigators examined four photographs sent from the customer.The investigators determined that the needles were bent.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The investigators concluded that the product problem occurred after the device left the manufacturing facility.
Additional Manufacturer Narrative
Correction: adverse event or product problem: corrected from product problem to adverse event.Additional information: a photograph of the device was examined by the investigator.An examination of the photograph revealed that the needle was bent.The device history record was also reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The investigator stated that the bending of the needle most likely occurred after the device left the manufacturing facility.

• Brand Name: DELTEC® GRIPPER PLUS® SAFETY NEEDLES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8446372
• Report Number: 3012307300-2019-01451
• Device Sequence Number: 2926783
• Product Code: FPA
• UDI-Device Identifier: 10610586015854
• UDI-Public: 10610586015854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 21-2734-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 06/04/2019; 06/04/2019; 06/04/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 07/23/2019; 09/11/2019; 09/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1