MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 22G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that when the device was attempted to be used, it was found that the individual wrapping was already rolled up a little.There was no reported patient involvement.(b)(6) 2022 - the lid of the returned sample was observed to not be adhered to the tray.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of an open package is confirmed and appears to be manufacturing related.One 22 ga huber plus was returned within its packaging.The product label indicated lot: refp1452.No apparent warping or deformation was noted on the kit packaging.The lower section of the lid was observed to not be adhered to the plastic tray flange.No evidence of seal transfer material was noted on the tray flange where the lid was not adhered to.The lid was peeled off a section that was adhered.The newly peeled region revealed seal transfer material to be left on the tray flange.The photos of the sample were sent to the manufacturing facility.The manufacturing facility confirmed the issue of the lid tray not being completely adhered to the lid tray; therefore, the complaint is confirmed.Bd is working closely with the manufacturing facility to prevent reoccurrence of the reported event.A lot history review (lhr) of refp1452 showed no other similar product complaint(s) from this lot number.

• Brand Name: HUBER PLUS 22G X 0.5IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15255320
• MDR Text Key: 305165280
• Report Number: 3006260740-2022-03227
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K993848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8012205
• Device Lot Number: REFP1452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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
• Patient Outcome(s): Other