MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 4F SINGLE-LUMEN PICC (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material present within the kit is inconclusive as the condition of the kit prior to kit opening could not be determined from the photo and video samples provided.One photo and one video sample were provided for evaluation.The first photo sample showed an opened groshong catheter kit with the catheter present within the tray.Fluid appears to be present within the tray.A red circle is drawn over a short, dark fiber present within the opened tray.The video sample shows a syringe being used to move the black fiber floating on the fluid within the tray.The condition of the kit prior to kit opening remains unknown; therefore, the complaint is inconclusive.Possible contributing factors include material deposition prior to or after kit opening.A lot history review (lhr) of recu1889 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that hair was found in the package.The device was not used.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC (60CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10101877
• MDR Text Key: 193131916
• Report Number: 3006260740-2020-01886
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00801741035326
• UDI-Public: (01)00801741035326
• Combination Product (y/n): N
• PMA/PMN Number: K871998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2020

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 Expiration Date: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 7717405
• Device Lot Number: RECU1889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• 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 Age: 68 YR
• Patient Weight: 64