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

Catalog Number 0132075

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

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 needle perforated the packaging was confirmed and considered supplier related. One photograph was provided for investigation. The physical sample was subsequently returned. The needle was protruding through the flexible tray film. Upon receipt of the sample, it was observed that the needle was protruding through a 1cm slit in the packaging. Three 1mm puncture sites were visible around the slit. The packaging material surrounding the slit exhibited sharp edges and no material deformation from stretching was observed. The needle cover was not present in the packaging. The outside diameter of the needle was within specification. Since the needle cover was not present, the complaint was determined to be supplier related. A lot history review (lhr) of ascns0182 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the needle was exposed inside of the package and it perforated the plastic packaging. It was stated that none of the staff members were stuck with the needle, and the device was not used on a patient.

• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7614458
• MDR Text Key: 111997720
• Report Number: 3006260740-2018-01433
• Device Sequence Number: 1
• Product Code: FPA
• 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,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0132075
• Device Lot Number: ASCNS0182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial