MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdqs0099 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
Event or Problem Description
It was reported that the nurse discovered that the extension tubing had blood backed up in it.The nurse assessed the huber needle set and noted that it was leaking from a crack located at the point were the extension tubing meets the female luer connector end.The old needle was removed and retained and the patient's ivad was re-accessed and the 28 day infusion resumed.
Event or Problem Description
It was reported that the nurse discovered that the extension tubing had blood backed up in it.The nurse assessed the huber needle set and noted that it was leaking from a crack located at the point were the extension tubing meets the female luer connector end.The old needle was removed and retained and the patient's ivad was re-accessed and the 28 day infusion resumed.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking infusion set was confirmed.The product returned for evaluation was two 20ga x 0.5¿ safestep safety infusion sets.Inspection of the first sample (sample 1) revealed abundant usage residues.A needleless injection cap was attached to the luer adapter and the safety mechanism was engaged.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a dully granular fracture surface.Beach marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The second sample (sample 2) was received in its original sealed packaging and was unremarkable to gross and microscopic inspections.The fracture features were consistent with material fatigue due to repetitive torsional (rotating) stress; however, an additional unidentified factor(s) may have affected the extension tubing mechanical properties.H3 other text : evaluation findings are in section h.11.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.5IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10945417
• Report Number: 3006260740-2020-20781
• Device Sequence Number: 983040
• Product Code: FPA
• UDI-Device Identifier: 00801741066320
• UDI-Public: (01)00801741066320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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-0037
• Device Lot Number: ASDQS0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other