MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER, 20G 10CM; INTRAVASCULAR CATHETER

Catalog Number	M120100
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a broken powerglide catheter was confirmed; however, the cause was undetermined.The product returned for evaluation was one photograph depicting a portion of a 10cm powerglide midline catheter.Visible in the photograph was the purple luer hub and a portion of luer-lock device attached to the hub.The catheter appeared to be detached distal of the hub and was not evident in the photograph.Red material which may have been blood/usage residue was observed just distal of the hub.While the catheter depicted in the submitted photograph appeared damaged, inspection of the photograph was insufficient to determine the root cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
Per sales representative, facility reported that they had an event reported regarding breakage of bard midline power glide at the pink end of the purple hub.No harm to patient.The midline was removed in its entirety, no retained catheter.Patient reported he had gotten his arm stuck on wheelchair which may have contributed to the break.
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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of midline catheter breakage was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 10cm powerglide midline catheter.The sample was received with a non-attached extension set.Usage residues were abundant throughout the sample.The catheter was received in two segments which shared a complete break just distal of the leur hub.Adhesive residue was abundant in the vicinity of the break.Also received was one photograph depicting the proximal sample segment.The luer hub exhibited curved shape memory near the distal end.Microscopic inspection of the break site revealed a partially rounded fracture edge.The fracture surface was granular; however, some material polish was observed.Material buckling was evident in the vicinity of the break and the break exhibited an elliptical cross-section.The material polish, rounded fracture edges, material buckling and elliptical cross-section were consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due repetitive kinking of the catheter tubing.The location of the damage suggested that catheter securement/placement technique may have contributed to the observed breakage.

• Brand Name: POWERGLIDE MIDLINE CATHETER, 20G 10CM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5919216
• Report Number: 3006260740-2016-00471
• Device Sequence Number: 16450704
• Product Code: FOZ
• UDI-Device Identifier: 00801741075322
• UDI-Public: (01)00801741075322
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2016

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: M120100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/31/2016
• Supplement Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1