MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult catheter insertion was confirmed and the cause was manufacturing-related.The product returned for evaluation was eight 18ga x 10cm powerglide pro midline catheter assemblies.All eight samples were received in their sealed packages.Microscopic inspection samples revealed irregular catheter tips.The catheter tips flared away from the needle shafts.The transition between the catheters and the needles appeared rough.The irregular and outward flaring catheter tips resulted in rough transitions between the introducer needles and the catheters.The catheter tips appeared to have been improperly formed during device manufacture.Photographs have been forwarded to the manufacturing site for further evaluation.A lot history review (lhr) of redz3053 showed seven other similar product complaint(s) from this lot number.

Event Description

It was reported the catheter is flared out and hard to penetrate the skin.No other information was provided.Eight device samples were returned.This report addresses the sixth device.

• Brand Name: PG PRO 18G 10CM BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10523404
• MDR Text Key: 206587607
• Report Number: 3006260740-2020-03245
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: F118100
• Device Lot Number: REDZ3053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2019
• 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