MAUDE Adverse Event Report: PALL MEDICAL A DIVISION OF PALL INTERNATIONAL SÀRL PALL "LIPIPOR" TNA FILTER; INTRAVENOUS FILTER

Model Number TNA1E

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

The tna1e filter associated with this incident was not retained by the user.Additionally the lot number of the implicated filter was unknown by the user and a review of the manufacturing records of the implicated lot could not be done.However the tna1e filter associated with the second incident (mfg.Report # 3008412416-2016-00002) described in the customer complaint was retained and has been received at pall's manufacturing site for investigation.This returned device will be evaluated and a final mdr for both incidents will be submitted upon completion of the filter investigation.

Event Description

The customer submitted one report to pall that on two occasions air was observed downstream of a pall lipipor tna filter (tna1e).This was first observed on (b)(6) 2016 and was then observed with a second filter on (b)(6) 2016.No adverse effects on the patient were reported with either incident.A separate medwatch report will be submitted for each incident (mfg.Report # 3008412416-2016-00001 and 3008412416-2016-00002).This mdr report (3008412416-2016-00001) is being submitted for the first noted incident on (b)(6) 2016.Note: implicated reorder code tna1e is not registered and sold in the us.All fda information below relates to a "like" product, reorder code tna1, which is registered for sale in the us.

Manufacturer Narrative

As communicated in the initial medwatch report, the implicated tna1e filter associated with this incident was not retained by the user.Additionally, the lot number of the implicated filter was unknown by the user and a review of the manufacturing records of the implicated lot could not be done.However, the tna1e filter associated with the second incident dated (b)(6) 2016 (mfg.Report# 3008412416-2016-0002), was retained and received for investigation.It should be noted that both occurrences were reported by the same customer and contained in one customer report.The filter was visually examined and no external abnormalities were observed.The sample was then sent to pall's scientific and laboratory services (sls) for testing.During the sls evaluation air was observed downstream of the filter, confirming the customer's observation.To further analyze the returned sample, the base and cover housing components were carefully removed and the exposed media visually examined.No physical damage was observed and both vent welds appeared complete.The main media coupon seals were also tested by submerging the filter in water and pushing air in through the outlet connection.Air bubbles were observed emanating between the main coupon and vent media.The main media weld area was examined under magnification and a bypass route was observed.A review of the manufacturing records for returned sample lot 16-546, as well as the associated filter sub-assembly (part number 112-0878, lot number 535603), was conducted.No deviations were noted.All quality control and release criteria were reviewed and confirmed to be within specification.This includes passing results for bubble point testing of the filter assembly which verifies membrane and seal integrity.A review of our complaint database confirmed that we have not received any other reports of a potential quality issue for the returned sample lot number 16-546, part tna1e.Additionally, a review of our complaint database for the last five years showed that this is the only confirmed customer report of an air downstream occurrence for the tna1e filter assembly.It is believed that a previous action taken by pall to reduce a potential deviation detected during our pre-release quality control testing will be effective in reducing the potential for the bypass failure mode seen in the returned filter.This investigation showed the root cause was a raw material issue related to the variation in the properties of the first sections of the media roll, causing insufficient weld of the main media coupon.In response to this a corrective action has been implemented in the form of a production start-up process to remove the media identified as causing the failures.No internal non-conformances related to this action have been detected since its implementation.It should be noted that the returned sample lot 16-546 was manufactured prior to the corrective action.No other action is being taken at this time.Unless substaintially significant information becomes available, this constitutes a final report.

• Brand Name: PALL "LIPIPOR" TNA FILTER
• Type of Device: INTRAVENOUS FILTER
• Manufacturer (Section D): PALL MEDICAL A DIVISION OF PALL INTERNATIONAL SÀRL; avenue de tivoli 3; fribourg, 1700 ; SZ 1700
• Manufacturer (Section G): PALL MEDICAL A DIVISION OF PALL INTERNATIONAL SÀRL; avenue de tivoli 3; fribourg, 1700 ; SZ 1700
• Manufacturer Contact: kathy zimmermann ; 25 harbor park drive; port washington, NY 11050 ; 5168019552
• MDR Report Key: 6090793
• MDR Text Key: 59968441
• Report Number: 3008412416-2016-00001
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K905794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TNA1E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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