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

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reav0172 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a hair inside the sterile package.Device was not used.
Additional 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 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 strand of hair in the package was inconclusive due to the sample condition.Two photographs were provided for investigation.The images were not in focus; however, what could be a strand of hair was observed between the gold sticker and the corner of the blue csr wrap in the close-up photo (2nd image).It could not be discerned if what appears to be a strand of hair is within the package or on the external surface.At this time, based on the condition of the evidence provided for investigation, the complaint could not be verified and was determined to be inconclusive.If the physical sample is returned for investigation, the complaint will be reassessed at that time.
Event or Problem Description
It was reported that there was a hair inside the sterile package.Device was not used.
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 of a strand of hair in the package was confirmed and determined to be manufacturing related since the hair was contained in a sealed needle guide kit.The hair was visible between the csr wrap and the inside surface of the tyvek packaging.The complaint sample was forwarded to the manufacturing facility for further review.Manufacturing facility evaluation: the complaint of ¿hair inside the sterile package¿ is confirmed; a hair was observed between wrap and tyvek which was trapped in the sealing process.The cause of this condition is manufacturing related.During the packaging process the product is 100% inspected by production personnel and is sampled by qc inspector.Production personnel were notified.
Event or Problem Description
It was reported that there was a hair inside the sterile package.Device was not used.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN)
• Common Device Name: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6472689
• Report Number: 3006260740-2017-00374
• Device Sequence Number: 13752812
• Product Code: ITX
• UDI-Device Identifier: 00801741037818
• UDI-Public: (01)00801741037818(17)180330(10)REAV0172
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2017

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: 03/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 9001C0212
• Device Lot Number: REAV0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: Not provided; 08/17/2017
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/10/2017; 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1