MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number 9001C0212

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebt2285 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the device presented a hole.It was further reported that the cover presented a hole as well.The device was not used on a patient.

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 of a hole present in the probe cover is confirmed and appears to be use related.One site rite needle guide kit packaging with lot: rebt2285 and ref: 9001c0212 and one probe cover was returned for investigation.The probe cover was covered in gel.The probe cover was filled with water to determine the hole location.Two leaks were observed approximately 1.3 inches from the closed end of the cover.The leak locations were approximately 1 inch apart.A scratch in the cover was observed near the two leak locations.Microscopic observation revealed a slit in the plastic cover at the leak sites.The scratch in the cover and the two slits appear to have been caused by contact with a sharp instrument; therefore, the complaint is confirmed, use related.A lot history review (lhr) of rebt2285 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the device presented a hole.It was further reported that the cover presented a hole as well.The device was not used on a patient.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7498918
• MDR Text Key: 107828545
• Report Number: 3006260740-2018-00937
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037818
• UDI-Public: (01)00801741037818
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 9001C0212
• Device Lot Number: REBT2285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1