MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX; FORCEPS, GENERAL & PLASTIC SURGERY

Catalog Number 320559

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: samples were received and an investigation was performed.Visual examination was carried out on the returned samples and photos and a broken non patient end of cannula was observed on three samples, a bent non patient end of cannula was observed on six samples, no issues were observed with the remaining one sample.No dhr review can be carried out as lot number is unknown.As all samples returned were open it is not possible to confirm this defect to be manufacturing related bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported when using the pen ndl 32g 4mm pro 14 bag 700 case jpx, the device experienced the cannula breaking off/ pulling out.This event occurred 10 times.The following information was provided by the initial reporter.The customer stated: the customer reported that the needle npe was found to be bent in some products.

• Brand Name: PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12565284
• MDR Text Key: 275523310
• Report Number: 9616656-2021-01229
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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