MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rees1531 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "we were placing a picc and went to put the probe cover on and noticed a big hole in it".Additional info.Received 08/26/52020: was there patient harm reported?: no it was caught prior to use.A new needle guide/probe cover was opened.

Event Description

It was reported "we were placing a picc and went to put the probe cover on and noticed a big hole in it." additional info.Received 08/26/52020: was there patient harm reported?: no it was caught prior to use.A new needle guide/probe cover was opened.

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged probe cover is confirmed; however, the exact cause is unknown.One probe cover was returned for evaluation.An initial visual observation showed a clear viscous fluid (most-likely ultrasound gel) within the probe cover.Two slits or tears were observed in the probe cover near its distal end.The larger slit was measured to be approximately 2.3 cm long and 1.1 cm proximal to the distal end of the probe cover, and the smaller slit was measured to be approximately 0.6 cm long and 1.7 cm proximal to the distal end of the probe cover.A microscopic observation revealed plastic deformation around the edges of the slits, which were observed to be mostly straight.The corners of the slits appeared to be somewhat pinched.It could not be determined from the evidence observed on the returned sample if the probe cover was damaged prior to, during, or after use.As a note, the product ifu cautions: ¿always snap the needle guide on to the probe hook.Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear.¿ a lot history review (lhr) of rees1531 showed no other similar product complaint(s) from this lot number.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10554934
• MDR Text Key: 207572320
• Report Number: 3006260740-2020-03314
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771
• Combination Product (y/n): N
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REES1531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1