MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE FILTER BLUNT FILL 18X1-1/2; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305211

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown: (b)(6) usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that an unspecified number of needle filter blunt fill 18x1-1/2 experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 305211 batch no.: unknown.Verbatim: we just opened a box of these blunt fill needles with filter, and it was filled with item 305180 blunt fill needles.Lot #90565.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see section h.10.

Event Description

It was reported that an unspecified number of needle filter blunt fill 18x1-1/2 experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: material no.: 305211, batch no.: unknown.Verbatim: we just opened a box of these blunt fill needles with filter, and it was filled with item 305180 blunt fill needles.Lot #90565.

• Brand Name: NEEDLE FILTER BLUNT FILL 18X1-1/2
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9324486
• MDR Text Key: 191112065
• Report Number: 1911916-2019-01206
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903052111
• UDI-Public: 30382903052111
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305211
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other