MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 42CM, ST WITH AIRGUARD; DIALYSIS CATHETER

Model Number	5734420
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that upon opening the package the device was missing.There was no reported patient contact.
Event or Problem Description
It was reported that upon opening the package the device was missing.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: a dhr cannot be performed as no lot number was provided by the complainant.Investigation summary: a sample evaluation could not be performed as the samples were not returned.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include improper training, personal fatigue, improper material handling ; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).The investigation is inconclusive due to the fact that no sample was returned for evaluation.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.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.

• Brand Name: HEMOSPLIT, 42CM, ST WITH AIRGUARD
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8592897
• Report Number: 3006260740-2019-01302
• Device Sequence Number: 2010773
• Product Code: MSD
• UDI-Device Identifier: 00801741013157
• UDI-Public: (01)00801741013157
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 5734420
• Device Catalogue Number: 5734420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1