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

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of hufr0255 showed seven other similar product complaint(s) from this lot number.The complaints for this lot number (hufr0255) have been reported from the same facility.

Event Description

It was reported "upon opening the package, there is mold in the gel caps.8 units were found similar in nature and they were pulled." no other information was provided.This report addresses the eighth device.

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), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of contamination in the pinpoint gel caps was confirmed and appears to be related to the manufacturing process.The products returned for evaluation were eight pinpoint gel caps.Of the returned samples, three were returned in open packaging while five were returned unopened.All of the gel caps were from the same lot, hufr0255.Gross visual observation of the samples revealed contamination on all of the gel caps, with the contamination on the sealed gel caps visible through the device packaging.The contaminant appeared to be small spots that appeared dark under gross visual examination but appeared a brownish/beige under microscopic examination.Dimensions were taken on a subset of the spots on some of the samples.The spots ranged in size from 0.00350¿ to 0.11623¿.Dark specks were seen within most of the spots.The area inside the spots was lighter than the external edges of most of the spots.Some of the spots contained a mottled appearance and/or an iridescent sheen.The front side of the gel pads appeared free of contaminants.To verify this, the gel pads on a subset of samples were cut longitudinally and a visual inspection of the cross section of the gel revealed that the contaminant was on the back side of the gel but was not present on the front side or embedded within the gel.Two of the sealed packages were functionally tested by fully submerging the packaging in a beaker of blue dyed water.No bubbles were seen emanating from the packaging into the beaker during submersion.After the samples had been submerged, they were opened and examined for blue dye infiltration through the seals or lidstock.No blue dye was seen within the packaging, indicating that there were no breaches in the packaging seal or in the lidstock material.The product sterilization certificate was reviewed which showed that the minimum and maximum dose of gamma sterilization were within the specified range.Samples from similar complaint files were forwarded to the bd materials science & engineering center of excellence for further chemical analysis to try to identify the contaminant.The samples were analyzed using optical microscopy and scanning electron microscopy (sem) with energy dispersive spectroscopy (eds).Eds detected that the spots were composed of copper in addition to the elements that are part of the pinpoint gel material.As the returned samples all showed copper contamination, they will be confirmed.Most of the returned samples were returned sealed and there was no damage to the seals or lidstocks.Therefore, it appeared that the contaminants entered the kits prior to sealing the packaging.The contamination was likely related to the manufacturing process and equipment.The end-item manufacturing facility has been notified of this complaint.Bd is working closely with manufacturing to prevent recurrence of the reported event.

Event Description

It was reported "upon opening the package, there is mold in the gel caps.8 units were found similar in nature and they were pulled." no other information was provided.This report addresses the eighth device.

• Brand Name: PINPNT GELCAP, WO GUIDE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 12371304
• MDR Text Key: 268265754
• Report Number: 3006260740-2021-03532
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9A10000
• Device Lot Number: HUFR0255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Date Manufacturer Received: 09/30/2021
• 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