MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER; INTRAVASCULAR CATHETER

Model Number N/A

Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 rezj0900 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the catheter was placed successfully to vena but when trying to remove needle+wire through the catheter, they got stuck.The doctor had to remove catheter from the vein.It was stated that the catheter had broken (partially loose) from the external hub.

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 device returned was found during preliminary evaluation to be one 8 cm, 18 ga powerglide device.Visual observation found the needle was bent out from the housing of the device, with the bend near the needle hub.The catheter advancement wings with the safety can mechanism of the needle, and the hub of the catheter, were found along the needle.However, the catheter was broken near the strain relief, and was found at the tip of the needle, with a great deal of bunching at this point.An extensive amount of use residue, apparently dried blood, was found at this point and along the catheter, and on the needle.The guidewire was partly within the catheter and bent at the junction of the needle and catheter.Tactual evaluation found the catheter insertion wings were mobile, but the catheter hub was not.That the catheter was bunched up and broken at the junction of the needle and guidewire, and that here the guidewire was bent, indicates that a concentration of stress occurred at this point, resulting in the breakage of the guidewire.This is known to occur when the needle and catheter are pressed together, such as when manipulating the catheter back and forth while on the needle, or attempting to position the catheter while the needle tip is still within the catheter.This complaint is therefore use-related.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 following statements from the ifu may be helpful: ¿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.¿.

Event Description

It was reported that the catheter was placed successfully to vena but when trying to remove needle+wire through the catheter, they got stuck.The doctor had to remove catheter from the vein.It was stated that the catheter had broken (partially loose) from the external hub.

• Brand Name: POWERGLIDE MIDLINE CATHETER
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6504542
• MDR Text Key: 73189821
• Report Number: 3006260740-2017-00441
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741095436
• UDI-Public: (01)00801741095436(17)170928(10)REZJ0900
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Model Number: N/A
• Device Catalogue Number: 6020080
• Device Lot Number: REZJ0900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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