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

Catalog Number	21-2733-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/10/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a deltec® gripper® needle was used with a port-a-cath and kept in situ when it was observed that the needle had broken off from the rest of the device and the needle remained inside the port with the end exposed outside of the patient's skin.The device had been in use for five days for daily intravenous treatment the issue was observed by the patient's parents when it was discovered that the gauze dressing that protected the needle was stained with blood.The broken needle was reviewed by a doctor and successfully removed.The patient's port had to be accessed more frequently for treatment due to the device issue.No permanent injury was reported.See mfr: 3012307300-2017-00824.
Additional Manufacturer Narrative
One used deltec® gripper® needle was returned for investigation.During visual inspection, it was observed the sample was received with the needle broken.The complaint was confirmed.A manufacturing review of a similar device was performed and no discrepancies were found.No root cause was able to be determined due to there being no evidence that the manufacturing process could create a weakness to the needle.

• Brand Name: DELTEC® GRIPPER® NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6446560
• Report Number: 3012307300-2017-00782
• Device Sequence Number: 719895
• Product Code: FPA
• UDI-Device Identifier: 10610586015847
• UDI-Public: 10610586015847
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K870866
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2017

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
• Operator of Device: Nurse
• Device Catalogue Number: 21-2733-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PORT-A-CATH
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 MO
• Patient Weight: 13