MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 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 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.A total of 57 gel caps were returned for evaluation: 42 pinpoint assessment gel caps and 15 gel caps for vascular access.All packages were labeled with lot number hufr0001.Twelve of the samples were received in open packaging while 45 of the samples were returned in sealed packaging.Of the 45 returned sealed samples, 34 were verified to have contamination visible on the hydrogel pad through the packaging.The other 11 samples did not have contamination visible through the packaging.However, once the packages were opened, contamination was present on all except three samples.Gross visual and /or microscopic visual inspection of all the opened gel caps confirmed the presence of contamination present on the hydrogel pads.The contamination usually presented as small irregular shaped spots on the back of the gel pad.The spots did not appear to be uniformly distributed.Dark specks were seen within most of the spots under microscopic examination.The contaminated spots were brownish beige in color and were darker on the external edges of the spots.Some samples contained spots with a mottled appearance and/or an iridescent sheen.One of the samples showed smaller specks on the gel but did not contain the larger spots visible on the other samples.The front side of the gel pads appeared free of contaminants.To verify this, the gel pad on a subset of samples was split 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 within the body of the gel.Three 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.Bioburden testing was conducted on this lot prior to sterilization as part of a dose audit.A review of the bioburden results was unremarkable, as the tested samples all met the acceptance criteria for bacterial and fungal contamination.The product sterilization certificate was reviewed which showed that the minimum and maximum dose of gamma sterilization were within the specified range.Two of the complainant 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.As 54 of the returned samples 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.A lot history review (lhr) of hufr0001 showed 74 other similar product complaint(s) from this lot number.

Event Description

It was reported via phone call "customer stated that when they open the package there was mold in the product." this occurred with 54 gel cap devices.This report addresses the 43rd gel cap device.

• Brand Name: PINPNT GELCAP, WO GUIDE,
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12594813
• MDR Text Key: 275386358
• Report Number: 3006260740-2021-04278
• 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
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: HUFR0001
• 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