MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 18G 8CM FULL; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility, via the sales rep, that during injection for ct the powerglide catheter was noted to be blocked between the lumen and the catheter.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 an occluded powerglide catheter was confirmed and the cause of the occlusion appears to be related to use of the device.One 18g x 10cm powerglide was returned for investigation.A non-bas extension set was attached to the powerglide luer adaptor.Evidence of use was observed on the returned sample.Residue from what was most likely a dressing was observed on the external surface of the extension set.Fluid was observed in the extension set tubing.A functional test confirmed that both the extension set tubing and powerglide catheter were occluded.An attempt was made to dislodge the occlusion from the powerglide catheter with a guidewire, but the obstruction could not be cleared.The catheter was cut just distal to the green strain relief sleeve and a microscopic examination revealed crystallized material within the catheter lumen.It appeared that the occlusion developed within the catheter from the substance that was injected through the extension set and catheter.The product ifu provides suggestions for catheter maintenance.The ifu states, ¿flush the catheter with 10 ml of sterile saline every 12 hours or after each use or per facility protocol using a 10ml or larger syringe.¿.
Event or Problem Description
It was reported by the facility, via the sales rep, that during injection for ct the powerglide catheter was noted to be blocked between the lumen and the catheter.No harm to the patient was reported.

• Brand Name: DOT PG PRO 18G 8CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6672341
• Report Number: 3006260740-2017-00916
• Device Sequence Number: 16637382
• Product Code: FOZ
• UDI-Device Identifier: 00801741110658
• UDI-Public: (01)00801741110658
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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 Model Number: N/A
• Device Catalogue Number: F218081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1