MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; 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	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the infusion set tubing was confirmed.The product returned for evaluation was a 19g x 0.75¿ safe step safety infusion set.A circumferential split was seen in the tubing directly distal of the luer adaptor.The split traversed approximately ¾ of the way around the circumference of the tubing.When an attempt was made to flush the returned device, a spraying leak was observed emanating from the split in the tubing.Microscopic examination of the split site revealed a dull and granular break surface with irregular striations that radiated outward.The break had occurred directly distal of the adhesive fillet of the luer adaptor.No apparent defects were seen in the adhesive fillet or the infusion set tubing.The infusion set tubing was cut by the investigator approximately 4¿ distal of the luer adaptor.The inner diameter, outer diameter and wall thickness of the tubing were measured at this location and were found to meet the device specifications.The characteristics seen on the returned device were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have also contributed.A lot history review (lhr) of asexf021 showed three other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "extension tubing is cracking, causing leaking in less than 48 hours of infusion.".

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 0.75IN
• 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: 11532127
• Report Number: 3006260740-2021-00907
• Device Sequence Number: 4091684
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2021

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-0033
• Device Lot Number: ASEXF021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/19/2021
• 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