MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE, 22G10CM; INTRAVASCULAR CATHETER

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 reaw0933 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, the facility reported the powerglide needed to be replace the day after it was inserted because they were not able to flush the line.It was stated that it was removed and a kink was found about 4 cm from the hub (kinked within the vessel, not at the hub).No patient harm reported.
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 kinked powerglide catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 10cm x 20ga powerglide midline catheter.Usage residues were observed throughout.The catheter was received attached to a 3ml syringe.The catheter was sharply kinked just distal of the luer hub.A second permanent kink impression was observed 5.5cm from the distal tip of the catheter.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion with no observed leaks.Microscopic inspection of the sample confirmed the presence of two distinct permanent kink impressions.Multiple partially circumferential impressions were observed along the inner radius of both kink impressions.The kink impressions appeared to be the result of sample handling/ manipulation.The usage residues suggested that manipulation occurred during device placement or subsequent securement/use.The product ifu states ¿minimize catheter/tube manipulation during application and removal of the statlock stabilization device.¿.
Event or Problem Description
Per sales representative, the facility reported the powerglide needed to be replace the day after it was inserted because they were not able to flush the line.It was stated that it was removed and a kink was found about 4cm from the hub (kinked within the vessel, not at the hub).No patient harm reported.

• Brand Name: POWERGLIDE, 22G10CM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6527346
• Report Number: 3006260740-2017-00527
• Device Sequence Number: 954460
• Product Code: FOZ
• UDI-Device Identifier: 00801741096877
• UDI-Public: (01)00801741096877(17)170831(10)REAW0933
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

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 Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: M220101
• Device Lot Number: REAW0933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1