MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
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 was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 20 ga x 1 in safestep infusion set.The returned product sample was evaluated and the needle was observed to be bent at the proximal end of the needle shaft.The following observations were noted during the sample evaluation: the needle was bent at the region where the needle extends from the base, microscopic examination of the sample found no supporting evidence of a specific root cause.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event.A lot history review (lhr) of ascts0082 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle tip was bent.12/12/2019 - the returned sample showed that the bend in the needle prevented the safety mechanism from activating.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9501314
• Report Number: 3006260740-2019-03960
• Device Sequence Number: 16644714
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• 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): 12/19/2019

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-0032
• Device Lot Number: ASCTS0082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1