MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Thrombus (2101)

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redp1982 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).

Event Description

It was reported that this patient had a high fever.Removed the catheter and found fluid leaks at the 29 cm mark of the catheter inserted.No other information was provided.

Event Description

It was reported that this patient had a high fever.Removed the catheter and found fluid leaks at the 29 cm mark of the catheter inserted.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.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 fluid leak is confirmed but the exact cause could not be determined from the video sample provided.One video sample of a groshong catheter was provided for evaluation.The sample is shown outside of use and is being handled by a clinician.The catheter is being stretched and infused with a clear fluid.Fluid is observed to leak at the location being held.The split could not be clearly seen through the video.Since the characteristics of the split could not be evaluation, the exact cause of the split could not be determined; therefore, the complaint is confirmed, cause unknown.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of redp1982 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in china.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI
• 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
• MDR Report Key: 9917303
• MDR Text Key: 186605578
• Report Number: 3006260740-2020-01155
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296
• Combination Product (y/n): N
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REDP1982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention