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
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3006260740-2020-20113
• Device Sequence Number: 4123100
• Product Code: LJS
• UDI-Device Identifier: 00801741035289
• UDI-Public: (01)00801741035289
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Model Number: N/A
• Device Catalogue Number: 7715305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other