MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 3F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the health (b)(4) website that a facility reported a crack/fluid leak and hemorrhage/bleeding.It was reported there was unexpected medical intervention and delay to treatment/therapy.No further information.Cause not established.

Manufacturer Narrative

H6.Investigation: the complaint of a leak was inconclusive because no sample was returned to vad for evaluation.The lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A device history review (dhr) cannot be performed as no lot number was provided by the complainant.

Event Description

It was reported by the health canada website that a facility reported a crack/fluid leak and hemorrhage/bleeding.It was reported there was unexpected medical intervention and delay to treatment/therapy.No further information.Cause not established.

• Brand Name: GROSHONG 3F SINGLE-LUMEN PICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10679978
• MDR Text Key: 213414039
• Report Number: 3006260740-2020-20113
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035289
• UDI-Public: (01)00801741035289
• Combination Product (y/n): N
• PMA/PMN Number: K926331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• 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: 7715305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other