MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFETY HUBER 22G X 0.75IN WITH NF VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	583112
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.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 cracks in the needle housing was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 22ga x 0.75¿ safety huber safety infusion set.The sample was received with the safety mechanism not engaged and appeared free of obvious usage residues.Multiple cracks were observed in the needle housing.An attempt to infuse water through the sample using a 12ml syringe revealed leakage emanating from the proximal end of the needle housing.Microscopic inspection of the sample confirmed the presence of cracks in the needle housing, creating a fluid path to the leak site.The cracks progressed along the proximal tapered bore in the housing, extending to the distal end of the housing.The cracks appeared consistent with internal hoop stress along the tapered bore in the housing.The development of these fracture features appeared to coincide with introduction of new production mold.
Event or Problem Description
During the evaluation of the sample the engineer discovered that the returned sample exhibited cracks in the needle housing which resulted in a leak.

• Brand Name: SAFETY HUBER 22G X 0.75IN WITH NF VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7539206
• Report Number: 3006260740-2018-01056
• Device Sequence Number: 1187017
• Product Code: FPA
• UDI-Device Identifier: 00801741044885
• UDI-Public: (01)00801741044885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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 Catalogue Number: 583112
• Device Lot Number: REBW1881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1