MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH TUBE SET FOR SUCTION SINGLE-USE; HYSTEROSCOPY PUMP AND SCALE

Model Number	AQL-111
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot: k18g175 manufacturing date: 2018-07-01 expiration date: 2021-07-01.Lot: k18k265 manufacturing date: 2018-09-01 expiration date: 2021-09-01.The tube set for suction single-use aql-111 is packaged in a double blister.The complaint only states that it "appears" as if there are tiny pin holes in the packaging.This error description based on "optical pin impressions" does not conform an actually pierced sterile barrier.To pierce through one blister a certain amount of force is required and such damage would be visible.Therefore, considering that even in the unlikely event of a perforation, not both blisters are necessarily pierced.Corresponding transportation tests had been carried out and passed during development.The root cause cannot be determined yet, as we did not receive the tube sets for investigation.We could also not obtain further information from the complainant.However, the manufacturing site infus medical (b)(4) co., ltd.Checked the retain samples (3 units each lot) and could not determine any damage in the inner or outer blister nor to the sterile barrier.Also the dhrs do not show any abnormali-ties or deviations.The aql-111 belongs to the group of internally designated st282 tube sets.This is the first complaint of this kind of a total of (b)(4) delivered st282 tube sets until today.It cannot be excluded or con-firmed that a malfunction exists in this case, therefore an initial report will be filed.Wom will continue to attempt to obtain information and tube sets from the complainant and will monitor very closely over the next three months whether there are any other similar complaints.We acknowledge that we are filing this report past the 30-days frame.The individual who made the initial assessment for reportability erred and this was caught upon secondary review.
Event or Problem Description
We have been informed of the following event: "(b)(6) reports she has aquilex tubing of lots k18g175 and k18k265 that appear to have tiny pin holes in the package and some sort of tiny particles rubbing from inside creating these holes.".
Event or Problem Description
We have been informed of the following event: "(b)(6) reports she has aquilex tubing of lots k18g175 and k18k265 that appear to have tiny pin holes in the package and some sort of tiny particles rubbing from inside creating these holes.".
Additional Manufacturer Narrative
Wom filed the initial report on 29-nov-2019 (mfr no.3002914049-2019-00017).Wom attempted to obtain information and tube sets from the complainant, but neitehr additional information nor the devices were provided.Wom monitored closely over the three months whether there are any other similar complaints.None similar complaints were filed with wom.Wom closed the files on this event.

• Brand Name: TUBE SET FOR SUCTION SINGLE-USE
• Common Device Name: HYSTEROSCOPY PUMP AND SCALE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 9394564
• Report Number: 3002914049-2019-00017
• Device Sequence Number: 2669404
• Product Code: HIG
• UDI-Device Identifier: 04056702002190
• UDI-Public: 04056702002190
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: AQL-111
• Device Catalogue Number: AQL-111
• Device Lot Number: K18G175 , K18K265
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1