MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 10CM BASIC KIT (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Catalog Number F120100

Device Problems Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

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

Event Date 04/25/2017

Event Type  malfunction  

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, 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 that the guidewire was not sticking out of the needle/safety mechanism was confirmed, but the root cause is unknown.One powerglide flex catheter and needle housing were returned for investigation.Evidence of use was observed on the returned sample.The catheter had been removed from the needle, the guidewire push-off button was fully advanced, the needle was slightly bent, and blood residue was observed on the sample.The safety mechanism had been activated and locked in place over the needle tip.The guidewire was observed within the housing, but was not attached to the coupler.What caused the guidewire to detach from the coupler is unknown, but this can occur if the guidewire push-off button was advanced while the guidewire was constrained in the needle and tissue.Without the wire attached to the coupler, the wire could not be advanced through the needle.The guidewire was complete and intact.After reassembling the guidewire to the coupler, a functional test revealed that the guidewire could be moved in and out of the needle with the push-off button.Due to the condition of the returned product, the guidewire may have detached from the coupler during use.A lot history review (lhr) of rebq0429 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales rep, the facility reported that the picc rn placed a 20g powerglide pro and when removing the housing after placement, noticed that the guidewire was not sticking out beyond the safety mechanism.It was stated that the rn was unsure if guidewire was present before procedure and unsure if guidewire was left in patient.The facility is still looking into the matter.

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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred per 21 crf 803.19.

Event Description

Per sales rep, the facility reported that the picc rn placed a 20g powerglide pro and when removing the housing after placement noticed that the guidewire was not sticking out beyond the safety mechanism.It was stated that the rn was unsure if guidewire was present before procedure and unsure if guidewire was left in patient.The facility is still looking into the matter.Sample evaluation shows the guidewire is intact and contained within the housing.The guidewire was out of the coupler so it could not be advanced into the vessel.

• Brand Name: PFLEX, 20G 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6575080
• MDR Text Key: 75619170
• Report Number: 3006260740-2017-00626
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110535
• UDI-Public: (01)00801741110535(17)190228(10)REBQ0429
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: F120100
• Device Lot Number: REBQ0429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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