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 Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recx4098 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that red foreign material was found in the powerglide package.No other information was provided.

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.6/20/2019 - 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 foreign material contained within the powerglide assembly was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 18ga x 10cm powerglide pro midline catheter assembly.The sample was received in its original sealed packaging.The device was removed from the packaging.During gross inspection of the device, red strand-like material was observed between the catheter and the needle shaft.The material was removed and examined using a digital microscope.The material appeared to be a fiber or suture-like material.The position of the material and the discovery upon removal from its sealed packaging indicated that the material was deposited during device assembly.

Event Description

It was reported that red foreign material was found in the powerglide package.No other information was provided.

• 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
• MDR Report Key: 8558116
• MDR Text Key: 143410858
• Report Number: 3006260740-2019-01205
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (y/n): N
• PMA/PMN Number: K153280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: RECX4098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1