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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that, "the needle had been in place since monday 15 feb.When going through the 10am antibiotics on feb 19, the dressing around the valve was found to be wet.The connector was not unscrewed, but the needle tubing was severed before the connector.".
Event or Problem Description
It was reported that, "the needle had been in place since monday 15 feb.When going through the 10am antibiotics on feb 19, the dressing around the valve was found to be wet.The connector was not unscrewed, but the needle tubing was severed before the connector.".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 damaged infusion set was confirmed; however, the precise root cause was not identified.The product returned for evaluation was one 20ga x 0.5¿ safestep safety infusion set.Usage residues were observed throughout the sample.The sample exhibited a complete break in the extension tubing at the luer/tubing joint.Microscopic inspection of the break site 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 break.The fracture features, discoloration and buckling were consistent with material failure due to flexural fatigue.Flexural fatigue occurs due to cyclic twisting and kinking of the tubing leading to gradual fracture formation and propagation.A change(s) in material properties may have contributed.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: 11530055
• Report Number: 3006260740-2021-00886
• Device Sequence Number: 14475941
• Product Code: FPA
• UDI-Device Identifier: 00801741066320
• UDI-Public: (01)00801741066320
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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