MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 0132075

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device has not yet been returned for evaluation.

Event Description

It was reported that the port access needle cap fell off twice while patient was at home, once while the patient was in the shower and a second time when they were receiving an infusion in the middle of the night.The needle was replaced.

Manufacturer Narrative

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 of needle cap disconnecting was inconclusive due to unknown use conditions.The products returned for evaluation were two 20 ga x 0.75 in w/y-site powerloc infusion sets.The samples were flushed with water using a 12 ml syringe and no leaks were observed.The luer taper gage was used to test the tapers and the proximal luers with the needleless injection caps attached were found to be out of specification.This is likely due to material creep caused by radiating stress within the luer hub orifice from over-tightening or use of slip fit attachments.As no leaks were observed when the connections were tightly secured and it is unknown how the connectors were secured at the time in which the alleged complaint occurred, the complaint is inconclusive due to unknown use conditions; however, the material creep may have been a contributing factor in the reported event.The product ifu states, "warnings: fully tighten all connections, y-site end caps, or needleless connectors before use.Failure to attach an end cap or appropriate needleless device after removing a male luer locking cap or needleless connector can result in an embolism or bleeding." this report addresses sample 1.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the port access needle cap fell off twice while patient was at home, once while the patient was in the shower and a second time when they were receiving an infusion in the middle of the night.The needle was replaced.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7584438
• MDR Text Key: 110801025
• Report Number: 3006260740-2018-01309
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0132075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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