MAUDE Adverse Event Report: LABOTECT LABOR-TECHNIK-GÖTTINGEN GMBH OVARIAN BIOPSY SET NO. 1; FOLLICLE ASPIRATON SET/NEEDLE

Catalog Number 16445

Device Problems Corroded (1131); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

The incident was considered a technical failure at the time and no mdr was completed.Discussion during an fda inspection and subsequent deliberations with the relevant fda policy branch led to the conclusion that there were no grounds for not reporting according to fda regulation.

Event Description

This product was delivered to our distributor in (b)(4): ovarian biopsy set no.1, single lumen, o.D.1.4 mm, length 300 mm, tubing length 750/30/750 mm, red clips, plug for 14 ml tube, echo marking, corroded, sterile packed, ref16445, lot800809.On september 13, 2017, we received a complaint that the tip of the needle, where normally the echo marking is placed, was missing.The product has not been used on a patient.

• Brand Name: OVARIAN BIOPSY SET NO. 1
• Type of Device: FOLLICLE ASPIRATON SET/NEEDLE
• Manufacturer (Section D): LABOTECT LABOR-TECHNIK-GÖTTINGEN GMBH; kampweg 12; rosdorf, 37124 ; GM 37124
• Manufacturer (Section G): MÖLLER MEDICAL GMBH & CO KG; wasserkuppenstr. 29-31; fulda, 36043 ; GM 36043
• Manufacturer Contact: michael brzozowski ; kampweg 12; rosdorf, 37124 ; GM 37124
• MDR Report Key: 8840182
• MDR Text Key: 216415840
• Report Number: 9617654-2018-00001
• Device Sequence Number: 1
• Product Code: MQE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K003056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 16445
• Device Lot Number: 800809
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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