MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Catalog Number	7715305
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recv1351 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that rep received a product complaint from hospital for our groshong 3 fr basic kit (7715305).After catheter insertion within 24 hr they found a leakage in the catheter, so they told us they will going to remove the catheter.10-sep-2020 information received from customer: the leakage was external so whenever they infuse any medication or saline that was leaking, no blood leakage.Picc was placed so blood exposure was there.Some delay happened in medication delivery but they called the ir who placed the picc and he managed to repair the line with the second repair kit inside the kit which they kept safely, after that they are using the same line for all medication.As per the details provided by the dr their was some damage in the catheter externally and they managed to repair that.Staff managed to repair and use the same line.It was stated the nurse who placed this line is experienced and always uses a 10cc syringe for medication infusion and flushing.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASI
• Common Device Name: 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: 10547641
• Report Number: 3006260740-2020-03284
• Device Sequence Number: 3507240
• Product Code: LJS
• UDI-Device Identifier: 00801741035289
• UDI-Public: (01)00801741035289
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 7715305
• Device Lot Number: RECV1351
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1