MAUDE Adverse Event Report: PINPOINT GELCAP, WO GUIDE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9A10000

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of hufr0001 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the product received had incorrect labeling.Product that was ordered is 9a10000 but what was received is sa0728426.No other information was provided.

Event Description

It was reported that the product received had incorrect labeling.Product that was ordered is (b)(4) but what was received is (b)(4).No other information was provided.

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 batch history, applicable previous investigation(s), labeling, and sample analysis.Based on a review of this information, the following was concluded: the complaint that the reference number on the label was (b)(4) was unconfirmed since the product meets specifications.A total of 21 pinpoint gel caps were returned for evaluation.Twenty of the of the gel caps were intended for vascular access while one of the gel caps was intended for initial assessment.All packages were labeled with lot number hufr0001.The gel caps for vascular access were labeled as ref: 9a10000 while the assessment cap was labeled as ref: (b)(4).A review of the device case labeling revealed that each case of 9a10000 contains 50 pinpoint gel caps and 50 pinpoint assessment gel caps.The pinpoint assessment gel caps are labeled with reference number (b)(4) while the pinpoint gel caps are labeled with reference number 9a10000.As per the ifu, two gel caps should be used during the procedure.The pinpoint assessment cap ((b)(4)) should be opened and used for the initial assessment scan.During the initial assessment scan, note should be made of the vessel depth and anatomical location.The second gel cap (9a10000) should be used during the vascular access procedure.During vascular access, the cap is used to relocate the vessel identified during the assessment scan and to act as a coupling medium during access of the vasculature.Since the device labeling meets specifications, the complaint was unconfirmed.H3 other text : evaluation findings are in section h.11.

• Brand Name: PINPOINT GELCAP, WO GUIDE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12315726
• MDR Text Key: 266310165
• Report Number: 3006260740-2021-03276
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741091209
• UDI-Public: (01)00801741091209
• Combination Product (y/n): N
• PMA/PMN Number: K120882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9A10000
• Device Catalogue Number: 9A10000
• Device Lot Number: HUFR0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Outcome(s): Other