MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebt2062 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during catheter insertion the catheter kinked while it was being deployed.The picc nurse verified that the needle was in the center of the vessel via ultrasound.It was stated the guide wire was completely deployed, but the catheter only made it part of the way before it kinked.No harm to the patient was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 kink in the powerglide catheter was inconclusive due to the condition of the sample and since the reported damage could not be detected.One 18g x 10cm powerglide was returned for investigation.The catheter was received separate from the deployment system.The catheter had been removed from the wings.Blood residue was visible in the lumen.A microscopic examination revealed nothing remarkable.A tactual investigation revealed nothing remarkable.No kinks were identified in the powerglide catheter.A functional test revealed that the lumen was patent to infusion and no leaks were observed.The catheter may have been placed in a tortuous location; however, since the reported kink(s) could not be detected in the returned sample, the complaint was inconclusive.A lot history review (lhr) of rebt2062 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during catheter insertion the catheter kinked while it was being deployed.The picc nurse verified that the needle was in the center of the vessel via ultrasound.It was stated the guide wire was completely deployed, but the catheter only made it part of the way before it kinked.No harm to the patient was reported.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7310404
• Report Number: 3006260740-2018-00330
• Device Sequence Number: 1736578
• Product Code: FOZ
• UDI-Device Identifier: 00801741038112
• UDI-Public: (01)00801741038112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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 Model Number: N/A
• Device Catalogue Number: M118101
• Device Lot Number: REBT2062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1