MAUDE Adverse Event Report: P.J. DAHLHAUSEN & CO. GMBH, GERMANY; SPINAL NEEDLE (PENCIL POINT)

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 09/18/2015

Event Type  Other  

Manufacturer Narrative

Upon receipt of the complaint article, further investigation will be conducted to identify the cause.

Event Description

The hospital advised that needle broke during use.The broken part of the needle had been removed by surgery.The needle had been applied w/out any force.The patient is well and already left the hospital.

• Type of Device: SPINAL NEEDLE (PENCIL POINT)
• Manufacturer (Section D): P.J. DAHLHAUSEN & CO. GMBH, GERMANY
• Manufacturer (Section G): SAITAMA FACTORY; ko7i-1 nishikata,koshigaya,shi; saitama 343-0 822; JA 343-0822
• Manufacturer Contact: 2623-1 nishikata, koshigaya-shi; saitama 343-0-822 ; 89908250
• MDR Report Key: 5187855
• MDR Text Key: 30121926
• Report Number: 9681709-2015-00003
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR