MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD MYPICC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the customer received expired product was confirmed and a data recording error at the distribution center appeared to be a contributing factor in the reported event.One photo of a bard mypicc kit label with product code ck000458 and lot 18nb2700 was provided for investigation.The expiration date on the label was 2018-12-31.A review of the sales orders for this lot showed that ten (10) units were shipped to the customer after the expiration date on the label.No other customers received expired product.It was confirmed that the expiration date on the label was correct.The expiration date was incorrectly recorded in the system at the distribution center.Since the expiration date in the system had not been surpassed at the time of the shipments, expired product was allowed to leave the distribution center after the true expiration date that was printed on the unit label.A lot history review (lhr) of 18nb2700 showed nine other similar product complaint(s) from this lot number.The complaints for this lot number (18nb2700) have been reported from the same facility.
Event or Problem Description
It was reported that ten expired kits were sent to the facility.It was stated the packing slip had the expiration date as 12-31-2019 but printed on the individual kits was the date 12-31-18.The kits were not used.This report addresses the first kit.

• Brand Name: BARD MYPICC KIT
• 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: 8323985
• Report Number: 3006260740-2019-00220
• Device Sequence Number: 59034
• Product Code: LJS
• UDI-Device Identifier: 00801741104251
• UDI-Public: (01)00801741104251
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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 Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: CK000458
• Device Lot Number: 18NB2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1