MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM); INTRAVASCULAR CATHETER

Catalog Number	M120101
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
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 damaged powerglide catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was a 20ga x 10cm powerglide midline catheter.Blood residue was seen throughout the sample.The catheter contained a complete break 7.3 distal to the luer hub.The detached segment was not returned for evaluation.The safety mechanism was not engaged over the needle and was returned loose.Microscopic inspection of the catheter fragment revealed partially glossy and partially dull break surfaces.The break profile appeared both tapered and triangular in shape.The catheter damage characteristics were consistent with damage caused by contact between the catheter and the introducer needle.Such contact can occur if the catheter is withdrawn against the needle bevel or if an attempt is made to re-insert the needle into the catheter.The product ifu states ¿once the catheter has been advanced, do not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 rezl0909 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On (b)(6) 2016 - per sales representative user facility reported that a picc nurse was placing a 10cm powerglide in the right basilica vein using ultrasound guidance.The wire inserted smoothly but would not advance entirely to the end where it locks.The nurse advanced the catheter and the catheter reportedly also failed to advance all the way.The nurse used the probe to scan the arm and it was said he thought he saw a bifurcation and assumed that's why the wire and catheter would not advance.He removed the entire device as one unit and said he felt nothing unusual and that it came out smoothly.The site was bleeding so he applied pressure with gauze.When the nurse looked at the powerglide, the needle was extended beyond the catheter and a portion of the catheter was missing.He picked the probe back up and scanned the arm and saw the catheter was still in the vein.He measured the remaining catheter on the sterile field and determined that there was about 2.75cm missing, left in the patient's vein.A surgeon performed a cut-down to remove the catheter.No other harm was caused to the patient.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT (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: 5600410
• Report Number: 3006260740-2016-00181
• Device Sequence Number: 834049
• Product Code: FOZ
• UDI-Device Identifier: 00801741038075
• UDI-Public: (01)00801741038075(17)161128(10)REZL0909
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2016
• Device Catalogue Number: M120101
• Device Lot Number: REZL0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2016
• Initial Report FDA Received Date: 04/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1