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	Serious Injury
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), applicable (b)(4) documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 8cm powerglide midline catheter assembly.The sample was received assembled.Usage residues were abundant throughout the sample.The catheter exhibited a complete break within the region of the molded joint.The distal catheter fragment overlaid the needle and guidewire.The catheter exhibited multiple kinks and bends along its length.Microscopic inspection of the wire confirmed it to be intact.Several coils were misaligned near the coil transition.Microscopic inspection of the catheter break site revealed sharply defined edges.The break surface exhibited a partially striated and partially granular texture.A triangular notch was observed in the molded joint.The several kinks and bends along the catheter length were typical of attempted catheter advancement against resistance.The catheter tubing break and molded joint notch were consistent with damage caused by retraction of the catheter against the needle bevel or needle re-insertion following catheter advancement.The product ifu states ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of recu1382 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the line was placed smoothly without any resistance but the guidewire would not come out.(b)(6) 2019 - additional information received: the placer told the bd tm that the guidewire and catheter inserted into the patient smoothly.When she went to remove the guidewire, she felt more resistance than normal and couldn't remove the wire.She tried pulling again but was unable to remove the wire.A doctor was called who also attempted to remove the wire without success.At some point during manipulation of the device, the catheter broke from the hub.The catheter and wire were successfully removed from the patient.The placer did state that the needle never fully retracted.

• 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: 8370942
• Report Number: 3006260740-2019-00370
• Device Sequence Number: 1598832
• Product Code: FOZ
• UDI-Device Identifier: 00801741038150
• UDI-Public: (01)00801741038150
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: M122081
• Device Lot Number: RECU1382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 MO