MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PENCAN; SPINAL NEEDLE

Model Number N/A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received one used pencan 0,53/103(g25 x 4")+0,9/35(g20) without packaging.The provided sample was taken to a visual examination.The pencan cannula and the mandrin are not assembled.The used pencan cannula is broken off approx.75 mm away from the cannula hub.The structure of the break of the raw cannula shows that the cannula was bent before the break.The broken-off part (approx.30 mm) with the cannula tip was not handed over by the customer.In addition, the outside diameter of the pencan cannula was measured according to drawing.Nominal-value: 0.53 +0.01/-0 mm.Actual-values: used sample = 0.53 mm.The measured values (outside diameters) of the pencan cannula is in accordance with specification.Although the complete device was not returned, with regard to the used sample, it is likely that this event is an application problem and consider the complaint to be not justified.Bmi device history record (dhr): reviewed the dhr and there is no abnormality found at final control inspection.All available information has been forwarded to the actual manufacturer.If additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): during surgery needle is broken.After taking a scan the operating doctor decided (in consult with the neurologist) to leave the remaining piece into the body of the patient, because it is in a place which causes no harm.

• Brand Name: PENCAN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5851946
• MDR Text Key: 51338287
• Report Number: 9610825-2016-00548
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2016,07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4502116
• Device Lot Number: 16C02G8220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2016
• Distributor Facility Aware Date: 07/14/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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