MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTABLE INFUSION SET 19G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 84446002

Device Problem Appropriate Term/Code Not Available (3191)

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 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 a damaged connector is inconclusive due to non-original sample return.One 19 ga x 1 in powerloc max infusion set was returned for investigation.The sample was returned in opened packaging with the protective needle sleeve and white end cap attached.No evidence of use was observed.The sample was flushed with water using a 12 ml syringe and was found to be patent to infusion.The sample was then pressurized and no leaks were observed.The luer hub was found to be within iso tolerance using a calibrated taper gauge.Since no deficiencies matching the complaint description were observed and no evidence of use was present, the complaint of a damaged connector is inconclusive due to non-original sample return.A lot history review (lhr) of asbys0035 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the hub at the end of the port needle widened so that blood collection was not possible since there was not airtightness created, this happened the second day after placement.A new needle had to be placed.

• Brand Name: POWERLOC MAX POWER-INJECTABLE INFUSION SET 19G X 1 IN
• 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: 7899758
• MDR Text Key: 121565183
• Report Number: 3006260740-2018-02550
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048111
• UDI-Public: (01)00801741048111
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 84446002
• Device Lot Number: ASBYS0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Outpatient Treatment Facility
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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