MAUDE Adverse Event Report: PALL NEWQUAY PALL BB25 ULTIPOR BREATHING CIRCUIT FILTER; PALL ULTIPOR25 BREATHING SYSTEM FILTER

Model Number BB25S

Device Problems Defective Component (2292); Connection Problem (2900); Infusion or Flow Problem (2964); Material Deformation (2976)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

The implicated devices were not returned to the firm for investigation.It was communicated that two (2) bb25s filters from lot# 20-1122 were observed with deformed ports.On initial visual inspection of the provided pictures, the port damage was clearly observed.On further review of the reported port damage it can be observed as a manufacturing issue.The most likely contributing root cause was determined to the ports were damaged during the 100% media integrity test.The damage highlights a direct link to the in process tester due to the size, shape and direction of the indentation observed on both ports.The machine consists of multiple parts including a rotating carousel which holds multiple filters while the stages of testing are conducted.There is a potential for the parts to clash with the carousel while being rotated resulting in the same damage observed to the ports.It is important to note that regular maintenance is conducted, and an hourly inspection is in place, while the area is being cleaned, to review the carousel.Due to the low occurrence rate of this issue no other action is deemed necessary at this time.The port damage observed would prevent the filter from being fitted to a breathing circuit due to the deformation of the ports.In conclusion and based on all the available data the customers report of port damage can be observed as a manufacturing defect.The occurrence rate for this issue is low and therefore no further action is deemed necessary at this time.It is important to note that no field action has been deemed necessary, the health hazard evaluation has been determined as severity of harm "medically reversible injury" and probability of harm "unlikely", this gives a classification of low.Based on four (4) mitigating factors: visual inspection prior to use will alert the end user to any potential problem with the product, alarms on the ventilator in use would detect any clinically significant product failure, the monitoring of the patient so any issues will be picked up in real time and the expiratory pathway from the filter remains intact protecting the environment from contamination.Ifu reviewed: the ifu section on installation states that to ensure the breathing system filter and any additional components are securely connected prior to use and that ventilator alarms should be in use at all times.The details on installation contained in the ifu have been deemed sufficient enough to negate any other customer communication.Unless substantially significant information becomes available, this constitutes as a final report.

Event Description

(b)(6) hospital reported that two (2) pall breathing filters, p/n bb25s, lot# 20-1122 were observed to have a deformed port and subsequently the breathing system filters leaked oxygen, this anomaly was never previously observed and the facility had the product replaced.On (b)(6) 2021, pall was first informed that the user reported this incident as adverse events (ae) to (b)(4) medical devices co.,ltd for adr monitoring, reference below adverse event details: 1st incident: ae report#: (b)(4).Patient was under general anesthesia when the laryngeal mask was connected to the patient and it was noted that there was a decline of blood oxygen.The doctor looked for the root cause and found after removing the filters, the patient's blood oxygen recovered.Upon checking the filters again, it was discovered that the port was deformed and not round as expected.It was additionally indicated that there was a leakage in the filter after connecting with the anesthesia machine.The hospital reported this as a severe injury.2nd incident: ae report#: (b)(4).Upon opening the primary package of the breathing system filter and connecting to the breathing loop, it was observed that the two components did not connect.The physician looked for the root cause and found a deformed port, whereby it was oval instead of round as expected.The hospital reported this as no patient injury.

• Brand Name: PALL BB25 ULTIPOR BREATHING CIRCUIT FILTER
• Type of Device: PALL ULTIPOR25 BREATHING SYSTEM FILTER
• Manufacturer (Section D): PALL NEWQUAY; st. columb major ind est; st. columb major, TR9 6 TT; UK TR9 6TT
• Manufacturer (Section G): PALL NEWQUAY; st. columb major ind est; st. columb major, TR9 6 TT; UK TR9 6TT
• Manufacturer Contact: richard borelli ; 25 harbor park drive; port washington, NY 11050 ; 5168019639
• MDR Report Key: 11916527
• MDR Text Key: 253746574
• Report Number: 9680602-2021-00001
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K791307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BB25S
• Device Lot Number: 20-1122
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention