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	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.
Event or Problem Description
It was reported that the infusion had been running for 6 days and the patient's mother noticed blood on the patient's shirt around the site of the ivad.The patient was taken to the inpatient unit where nursing removed the old needle and accessed the patient with a new one.It was stated, a nurse assessing the old needle set noted that it was leaking from a crack located at the point where the extension tubing meets the female luer connector.
Event or Problem Description
It was reported that the infusion had been running for 6 days and the patient's mother noticed blood on the patient's shirt around the site of the ivad.The patient was taken to the inpatient unit where nursing removed the old needle and accessed the patient with a new one.It was stated, a nurse assessing the old needle set noted that it was leaking from a crack located at the point where the extension tubing meets the female luer 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 leaking infusion set was confirmed.The product returned for evaluation was four 20ga x 0.5¿ safestep safety infusion sets.The first sample (sample 1) exhibited abundant usage residues and the safety mechanism was engaged.The other three samples were received in their original sealed packages.During inspection of sample 1 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 fracture features were consistent with material fatigue due to repetitive torsional (rotating) stress; however, an additional unidentified factor(s) may have affected tubing mechanical properties.The sealed samples were unremarkable and appeared to be sent as unused lot samples.A lot history review (lhr) of asdqs0185 showed no other similar product complaint(s) from this lot number.

• 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: 10944307
• Report Number: 3006260740-2020-20767
• Device Sequence Number: 11008650
• 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): 03/01/2021

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: ASDQS0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• 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