MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 18G 10CM BASIC KIT (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Catalog Number F118100

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Tissue Damage (2104)

Event Date 10/17/2016

Event Type  Injury  

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reau1899 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported to the sales rep that the picc nurse attempted to access the patients basilica vein.The nurse felt like the device was not in and pulled back.The nurse felt resistance, when she pulled the powerglide out the wire tip was gone and a piece of the catheter.The patient had to go to the operating room for removal of the catheter tip.The catheter tip was in the tissue, the wire was not found.

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 flex device was confirmed and the damage appears to be use related.The returned samples were two 18g powerglide flex deployment systems.One was for a 10cm midline catheter and the second was for an 8cm midline catheter.The product revealed evidence of use.Blood residue was observed on the returned samples.The catheter wings and catheters had been removed from each needle.The guidewire push-off button had been fully extended.Both needle tips were covered by the safety mechanism.The guidewire did not extend from the safety mechanism on the 10cm device.The guidewire extended beyond the tip of the safety mechanism on the 8cm device.No damage or defects were noted on the 8cm device.The safety mechanism was removed from the 10cm device.A microscopic examination of the inner edge of the needle bevel revealed deformation and impressions that are consistent with the guidewire coils.It appears that the needle was involved in damaging the guidewire and most likely caused damage to the catheter.The damage observed on the returned device is consistent with damage associated with use.This can occur by re-inserting the needle back into the catheter or pulling the catheter back over the needle during the placement process.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.The product ifu warns, ¿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.¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.¿ no further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

• Brand Name: PFLEX, 18G 10CM BASIC KIT (POWERGLIDE PRO)
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6126600
• MDR Text Key: 60845913
• Report Number: 3006260740-2016-00630
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511(17)180628(10)REAU1899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: F118100
• Device Lot Number: REAU1899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention