MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SL NG PREP 200BX; STATLOCK

Catalog Number	NG0120
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed.Visual inspection noted 3 photo samples were received.Visual evaluation of the photo samples determined that the box packaging had an expiration date of 2022-05-28, with the individual device packages had 2022-06 as the expiration date.This is a confirmed failure, via confirmation with the manufacturing site, as the box packaging should have had an expiration date of 2022-06-28.This is considered a failure per (b)(4) stating the product will be rejected if incorrect, illegible, or incomplete pad information.No corrective and preventative actions are required as the new erp system implementation at (b)(4) that was implemented after the manufacturing of this lot added an automatic expiration date calculation and removed human interface for this process.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be wrong label put on package.The product was not used for diagnosis or treatment.The product was influenced by the reported failure.The product failed to meet specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: "non-sterile.Ready to use.Product code, lot number and expiration date information¿see packaging.Remove oil and moisturizer from targeted skin area.Apply skin prep to the targeted statlock® device area for skin protection and enhanced pad adherence.Allow to dry completely.Safety and efficacy considerations: single use only.Rx only.Latex free.Contraindications: known tape or adhesive allergies.Warnings and precautions: avoid contacting the statlock® device with alcohol or acetone, both can weaken bonding of components and the statlock® device pad adherence.".
Event or Problem Description
It was reported that the analytical certificate they sent coincides with that of the box, but the piece indicates another expiration date.The box indicates an expiration of 05-28-2022 and the pieces have an expiration of june 2022.

• Brand Name: SL NG PREP 200BX
• Common Device Name: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10382475
• Report Number: 1018233-2020-05075
• Device Sequence Number: 19568190
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: Other
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: NG0120
• Device Lot Number: JUDUF502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1