MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. OBTURATOR FOR VENFLON/SAFELON1.0X32; INTRAVASCULAR CATHETER

Catalog Number 394252

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the obturator for venflon/safelon1.0x32 was delivered without a label.This was noticed prior to use.The following information was provided by the initial reporter, translated from german to english: "one packaging unit of the ref 394252 was delivered without labels, lot number 9200654.".

Event Description

It was reported that the obturator for venflon/safelon1.0x32 was delivered without a label.This was noticed prior to use.The following information was provided by the initial reporter, translated from german to english: "one packaging unit of the ref 394252 was delivered without labels, lot number 9200654.".

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed the bd obturator dispenser box with no label present to identify the gage, material, or lot of the product inside the shipper.The reported issue was confirmed.Shipper labels are printed off and placed on the dispenser boxes by operators during the packaging process.In this case an operator most likely did not place a dispenser label onto the box before placing it into a shipper.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the obturator for venflon/safelon1.0x32 was delivered without a label.This was noticed prior to use.The following information was provided by the initial reporter, translated from german to english: "one packaging unit of the ref 394252 was delivered without labels, lot number 9200654.".

• Brand Name: OBTURATOR FOR VENFLON/SAFELON1.0X32
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10571045
• MDR Text Key: 208776915
• Report Number: 1710034-2020-00606
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 394252
• Device Lot Number: 9200654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other