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

Catalog Number	21-2865-24
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and 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 during use the needle would not engage into the safety mechanism.No adverse health outcome resulted from this event.
Additional Manufacturer Narrative
The customer reported that two device contributed to two reported events (one device per event).In response to the reports, two initial medwatches: 2183502-2016-01105 and 2183502-2016-01159 were submitted.The customer returned two devices for evaluation.It could not be determined which device was associated with which reported occurrence; therefore, the evaluation of the two returned devices will be used for each medwatch follow-up.Visual examination of the returned devices found the first device to be free from any abnormalities or defects.The second device was found to have a bent needle; investigation was unable to determine the cause of the bend in the needle.Functional testing of both devices found them to operate as intended.Upon pulling on the device, both needles successfully locked into the capture shelves.The device history records of the reported lot revealed no non-conformities during manufacturing.The returned products were confirmed to operate as intended; no evidence was found to suggest the reported event was related to an intrinsic product fault.(b)(4).

• Brand Name: GRIPPER PLUS SAFETY NEEDLE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 5683781
• Report Number: 2183502-2016-01105
• Device Sequence Number: 16216533
• Product Code: FPA
• UDI-Device Identifier: 30610586025697
• UDI-Public: 30610586025697
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K021999
• 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
• Report Date (Section B): 05/26/2016

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: Other
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: 21-2865-24
• Device Lot Number: 35X1170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2016
• Supplement Report FDA Received Date: 08/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1