MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a bent needle is confirmed and appears to be related to the use of the device.One opened 22 ga x 1 in safestep infusion set was returned for investigation.The sample was returned with the white dust cap attached to the luer connector and with the needle protective cover over the needle.A sharp bend in the needle shaft extending from the base was observed.One photo sample of two 22ga safestep safety infusion sets was also returned.The top device in the photo was a 22ga x 1¿ safestep and is evaluated in this complaint file.The bottom device was a 22ga x 0.75¿ safestep and is evaluated in complaint 1474992.The device exhibited a needle bend at the exit site from the non-engaged safety mechanism.The sample appears to correspond to the returned physical sample.Microscopic observation of the needle bevel revealed the needle tip to be barbed inwards.Red use residue was also observed within the needle.The bend in the needle created additional resistance when attempting to activate the safety mechanism.The safety was able to be successfully advanced.Since evidence of use and advancement of the needle bevel against a solid surface was observed, it is likely that the bend occurred during use of the device.A lot history review (lhr) of ascys0161 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle was found bent prior to use.(b)(6) 2019 evaluation of the returned sample revealed the safety mechanism could not be activated using normal means and force.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 9252571
• Report Number: 3006260740-2019-03374
• Device Sequence Number: 2003145
• Product Code: FPA
• UDI-Device Identifier: 00801741066184
• UDI-Public: (01)00801741066184
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0030
• Device Lot Number: ASCYS0161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1