MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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 via phone call "that they have ordered hohn¿ central venous catheters ref#6600730, (2 each) and the size is not as listed on bd website which is 42cm length instead she got 24cm length." this report addresses the second of two catheters received.
Additional 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, applicable previous investigation(s), and website product listings.Based on a review of this information, the following was concluded: the complaint of an incorrect size listing on the bd product website was confirmed.The customer had reported that they believed to have ordered a 42cm length hohn catheter and received a 24cm length catheter.Further information was provided that the website had listed product catalog number 6600730 as a 42cm catheter.A review of the product bill of materials and unit label confirmed that the correct length for that catheter is 24cm, and another review of the following website url showed that the catheter length listed on the bd product information page was 42cm: https://www.Bd.Com/en-us/offerings/capabilities/vascular-access/vascular-iv-catheters/central-iv-catheters/hohn-central-venous-catheters/6600730.This page has since been updated and now correctly lists that catheter length as 24cm.
Event or Problem Description
It was reported via phone call "that they have ordered hohn® central venous catheters ref#6600730, (2 each) and the size is not as listed on bd website which is 42cm length instead she got 24cm length." this report addresses the second of two catheters received.

• Brand Name: HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT
• 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: 12282143
• Report Number: 3006260740-2021-03177
• Device Sequence Number: 19956897
• Product Code: LJS
• UDI-Device Identifier: 00801741036705
• UDI-Public: (01)00801741036705
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 6600730
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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