MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 0632010

Device Problems Tear, Rip or Hole in Device Packaging (2385); Material Protrusion/Extrusion (2979)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdzf005 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.Device not returned for evaluation.

Event Description

It was reported that part of the infusion set poked through the back of the package.It was reported this event occurred with two kits.This report addresses the second kit.

Event Description

It was reported that part of the infusion set poked through the back of the package.It was reported this event occurred with two kits.This report addresses the second kit.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damaged packaging is confirmed but the exact cause remains unknown.Two 20 ga x 1 in miniloc infusion sets were returned within sealed packaging.Both infusion sets were observed to have damage damaged packaging at the center of the clear film.The clear base tabs were found to be protruding through the clear packaging.One sample was found to have a partially fractured tab.The tyvek packaging was found to have wrinkling and a crease which may suggest the packages may have experienced compression.Based on the condition of the returned samples, possible contributing factors include compression damage leading to damage on the packaging and infusion set component.The location at which the damage occurred and source of the damage could not be determined from the information provided and likely occurred outside of bd control; therefore, the complaint is confirmed but the exact cause remains unknown.Evaluation findings are in section h11.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11069475
• MDR Text Key: 224341367
• Report Number: 3006260740-2020-21107
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047541
• UDI-Public: (01)00801741047541
• Combination Product (y/n): N
• PMA/PMN Number: K050600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0632010
• Device Catalogue Number: 0632010
• Device Lot Number: ASDZF005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other